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Enzyme
Combination Chemotherapy for T-Cell Leukemia/Lymphoma
Phase 3
Waitlist Available
Led By Stuart S Winter
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study
A diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years from end of induction
Awards & highlights
Study Summary
This trial is studying different combination chemotherapy regimens for T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Who is the study for?
This trial is for young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. It's not open to those with Down syndrome, unclassifiable lymphoma, CNS3-positive/testicular involvement, pregnant/lactating females, or B-precursor lymphoblastic lymphoma.Check my eligibility
What is being tested?
The study tests different combination chemotherapy regimens to see which is more effective against T-cell leukemia/lymphoma. Patients receive a common induction therapy first and then get assigned varying treatments based on their risk level and response.See study design
What are the potential side effects?
Chemotherapy drugs may cause side effects like nausea, hair loss, fatigue, increased infection risk due to low blood cell counts, mouth sores, and potential damage to organs such as the heart or liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had emergency chest radiation up to 600 cGy for airway issues.
Select...
My leukemia is classified as T-ALL based on specific cell markers.
Select...
I have been newly diagnosed with T-ALL or T-NHL at stage II-IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years from end of induction
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years from end of induction
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
+2 moreSecondary outcome measures
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Side effects data
From 2021 Phase 3 trial • 3154 Patients • NCT0007572572%
Neutrophil count decreased
57%
Infections and infestations - Other, specify
54%
Febrile neutropenia
47%
Alanine aminotransferase increased
39%
White blood cell decreased
39%
Platelet count decreased
32%
Hyperglycemia
27%
Anemia
24%
Aspartate aminotransferase increased
22%
Mucositis oral
19%
Hypokalemia
18%
Blood bilirubin increased
18%
Hyponatremia
16%
Anorexia
15%
Abdominal pain
15%
Vomiting
15%
Lipase increased
14%
Anaphylaxis
13%
Dehydration
13%
Headache
13%
Peripheral motor neuropathy
10%
Nausea
10%
Hypocalcemia
9%
Hypoalbuminemia
8%
Diarrhea
8%
Hypoxia
8%
Lung infection
8%
Peripheral sensory neuropathy
8%
Fibrinogen decreased
7%
Avascular necrosis
7%
Back pain
7%
Serum amylase increased
7%
Weight loss
7%
Enterocolitis infectious
6%
Depression
6%
Fever
6%
Hypotension
6%
Pancreatitis
6%
Hypophosphatemia
5%
Pain in extremity
5%
Arthralgia
5%
Epistaxis
5%
Lymphocyte count decreased
5%
Upper respiratory infection
5%
Hyperkalemia
5%
Skin infection
5%
Acute kidney injury
4%
GGT increased
4%
Pain
4%
Dyspnea
4%
Hypertension
4%
Oral pain
4%
Activated partial thromboplastin time prolonged
4%
Bone pain
4%
Typhlitis
4%
Hypertriglyceridemia
3%
Seizure
3%
Urinary tract infection
3%
Glucose intolerance
3%
Sinusitis
3%
Creatinine increased
3%
Encephalopathy
3%
Ileus
3%
Pneumonitis
3%
Syncope
3%
Anxiety
3%
Colitis
3%
Fatigue
3%
Rash maculo-papular
3%
Thromboembolic event
3%
Tumor lysis syndrome
3%
Nervous system disorders - Other, specify
3%
Esophagitis
3%
Catheter related infection
3%
Hypermagnesemia
2%
Cough
2%
Urticaria
2%
Disseminated intravascular coagulation
2%
Hemolysis
2%
Dysphagia
2%
Hypercalcemia
2%
Hepatic failure
2%
Acidosis
2%
Confusion
2%
Hypernatremia
2%
Non-cardiac chest pain
2%
Personality change
2%
Vascular disorders - Other, specify
2%
Anal mucositis
2%
Dysphasia
2%
Hypoglycemia
2%
INR increased
2%
Vascular access complication
2%
Pleural effusion
1%
Hepatobiliary disorders - Other, specify
1%
Abdominal infection
1%
Hematoma
1%
Capillary leak syndrome
1%
Gastrointestinal disorders - Other, specify
1%
Dizziness
1%
Allergic reaction
1%
Hepatic infection
1%
Psychosis
1%
Skin ulceration
1%
Pharyngitis
1%
Ascites
1%
Bone marrow hypocellular
1%
Facial nerve disorder
1%
Rectal pain
1%
Hyperuricemia
1%
Insomnia
1%
Intracranial hemorrhage
1%
Pancreas infection
1%
Pharyngeal mucositis
1%
Pneumothorax
1%
Proteinuria
1%
Muscle weakness lower limb
1%
Anal pain
1%
Cholecystitis
1%
Enterocolitis
1%
Hypomagnesemia
1%
Immune system disorders - Other, specify
1%
Investigations - Other, specify
1%
Iron overload
1%
Proctitis
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Stomach pain
1%
Musculoskeletal and connective tissue disorder - Other, specify
1%
Weight gain
1%
Blood and lymphatic system disorders - Other, specify
1%
Adult respiratory distress syndrome
1%
Myositis
1%
Pharyngolaryngeal pain
1%
Gastritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Prednisone and High Dose Methotrexate < 10 Yrs Old
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Prednisone, Capezzi Methotrexate >= 10 Years
Prednisone, Capizzi Methotrexate <10 Years
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Prednisone and High Dose Methotrexate >=10 Years
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Prednisone, Capezzi Methotrexate (Down's Syndrome)
Trial Design
17Treatment groups
Experimental Treatment
Active Control
Group I: Group 0 Induction TherapyExperimental Treatment6 Interventions
All patients (T-ALL and T-LLy) receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; prednisone IV or PO twice daily BID on days 1-28; pegaspargase IM (may give IV over 1 to 2 hours) on day 4, 5, or 6; daunorubicin hydrochloride IV on days 1, 8, 15 and 22; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease).
Group II: Group I Arm II (Delayed intensification chemotherapy)Active Control8 Interventions
Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.
Group III: Group I Arm I (Interim maintenance chemotherapy)Active Control4 Interventions
Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose (DS patients excluded as of 09/29/10).
Note: *Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2, 4, 6, 8, 10, 12, 22, 24, 26, 28, 30, and 32.
Group IV: Group I Arm III (Maintenance chemotherapy)Active Control3 Interventions
Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL) and all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).
Group V: Group I Arm III (Delayed intensification chemotherapy)Active Control9 Interventions
Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10).
Group VI: Group I Arm III (Consolidation chemotherapy)Active Control8 Interventions
Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.
Group VII: Group I Arm II (Consolidation chemotherapy)Active Control8 Interventions
Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35. Patients with high risk T-LLy were either randomized to Arm I or Arm II. Patients with T-LLy who failed induction therapy were assigned to Arm II.
Group VIII: Group I Arm I (Consolidation chemotherapy)Active Control8 Interventions
Patients receive methotrexate IT on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV over 15-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine sulfate IV on days 15, 22, 43 and 50; and pegaspargase IM or IV over 1-2 hours on days 15 and 43. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12, 15-19, and 22-26. (DS patients excluded as of 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT. Patients with standard risk T-LLy received Arm I, and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy.
Group IX: Group I Arm I (Delayed intensification chemotherapyActive Control9 Interventions
Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age and for patients with DS); doxorubicin hydrochloride IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose (DS patients excluded as of 09/29/10). Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II.
Group X: Group I Arm II (Maintenance chemotherapy)Active Control5 Interventions
Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).
Group XI: Group I Arm III (Interim maintenance chemotherapy)Active Control5 Interventions
Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.
Group XII: Group I Arm IV (Delayed intensification chemotherapy)Active Control9 Interventions
Patients receive vincristine sulfate IV on days 1, 8, 15, and 50; dexamethasone IV or PO BID on days 1-21 (for patients < 10 years of age) OR on days 1-7 and 15-21 (for patients >= 10 years of age); doxorubicin IV on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; methotrexate IT on days 1, 36, and 43; nelarabine IV over 60 minutes on days 29-33; cyclophosphamide IV over 30 minutes on day 36; cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46; and thioguanine PO on days 36-49.
Group XIII: Group I Arm IV (Interim maintenance chemotherapy)Active Control5 Interventions
Patients receive HDMTX IV over 24 hours and vincristine IV on days 1, 15, 29, and 43; mercaptopurine PO on days 1-56; and methotrexate IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses.
Group XIV: Group I Arm IV (Maintenance chemotherapy)Active Control5 Interventions
Patients receive vincristine sulfate, prednisone, mercaptopurine, methotrexate PO, methotrexate IT, and nelarabine in Cycles 1, 2 and 3. Patients then receive treatment (without nelarabine) as follows: vincristine, prednisone, mercaptopurine, methotrexate PO, and methotrexate IT as in arm II. Treatment (without nelarabine) repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 121) (for girls with T-ALL), and for those with T-LLY, and 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).
Group XV: Group I Arm I (Maintenance chemotherapy)Active Control5 Interventions
Patients receive vincristine sulfate IV on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61; mercaptopurine PO QD on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and methotrexate IT on day 1. Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy (approximately week 119) (for girls with T-ALL), all patients with T-LLy, and 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).
Group XVI: Group 1 Arm IV (Consolidation chemotherapy)Active Control7 Interventions
Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; methotrexate IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV over 15-30 minutes or SC on days 8-11, 15-18, 50-53 and 57-60; mercaptopurine PO on days 8-21 and 50-63; vincristine sulfate IV on days 22, 29, 64, and 71; and pegaspargase IM or IV over 1-2 hours on days 22 and 64. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15, 22-26, and 29-33 (DS patients excluded as of 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35.
Group XVII: Group I Arm II (Interim maintenance chemotherapy)Active Control4 Interventions
Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31.
Note: *Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday, Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Vincristine Sulfate
2005
Completed Phase 3
~10110
Prednisone
2014
Completed Phase 4
~2370
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Methotrexate
2013
Completed Phase 4
~3800
Pegaspargase
2005
Completed Phase 3
~9010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,931,258 Total Patients Enrolled
Stuart S WinterPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My T-NHL does not include specific types like B-precursor lymphoblastic lymphoma or involve the brain/testicles.I have not had chemotherapy, except for steroids or IT cytarabine.My leukemia is classified as T-ALL based on specific cell markers.I have been newly diagnosed with T-ALL or T-NHL at stage II-IV.I've had IT chemotherapy with cytarabine for convenience before joining.I have T-NHL or T-ALL and may need steroids before starting treatment, affecting my risk classification.I've had emergency chest radiation up to 600 cGy for airway issues.I haven't taken seizure medications or had significant nerve damage in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Group I Arm II (Delayed intensification chemotherapy)
- Group 2: Group I Arm I (Interim maintenance chemotherapy)
- Group 3: Group I Arm III (Maintenance chemotherapy)
- Group 4: Group I Arm III (Delayed intensification chemotherapy)
- Group 5: Group I Arm III (Consolidation chemotherapy)
- Group 6: Group I Arm II (Consolidation chemotherapy)
- Group 7: Group I Arm I (Consolidation chemotherapy)
- Group 8: Group I Arm I (Delayed intensification chemotherapy
- Group 9: Group I Arm II (Maintenance chemotherapy)
- Group 10: Group I Arm III (Interim maintenance chemotherapy)
- Group 11: Group I Arm IV (Delayed intensification chemotherapy)
- Group 12: Group I Arm IV (Interim maintenance chemotherapy)
- Group 13: Group I Arm IV (Maintenance chemotherapy)
- Group 14: Group I Arm I (Maintenance chemotherapy)
- Group 15: Group 0 Induction Therapy
- Group 16: Group 1 Arm IV (Consolidation chemotherapy)
- Group 17: Group I Arm II (Interim maintenance chemotherapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions does Daunorubicin Hydrochloride help to treat?
"Daunorubicin Hydrochloride is often used to treat macular edema. It is also an effective medication for treating other conditions like pheochromocytomas, ulcerative colitis, and certain types of eye cancer."
Answered by AI
Are there any US-based medical facilities testing this drug yet?
"This clinical trial is taking place in many locations, some of which include Hackensack University Medical Center in Hackensack, Indiana, Ascension Saint Vincent Indianapolis Hospital in Indianapolis, South carolina, and Prisma Health Richland Hospital in Columbia, Tennessee."
Answered by AI
Does the age limit for this trial restrict potential participants to those over 25 years old?
"Eligible patients for this trial must between 1 and 30 years old."
Answered by AI
To your knowledge, is this research the initial step in its area?
"Daunorubicin Hydrochloride has had a long history of clinical trials, with the first one taking place in 1997. 300 patients were studied in the initial Phase 3 clinical trial, which was sponsored by Alfacell. After the success of the 1997 trial, Daunorubicin Hydrochloride received drug approval and is now being trialed in 2306 different clinical trials across 3812 cities and 89 countries."
Answered by AI
Could you please explain the requirements for participants in this clinical trial?
"This trial is looking for 1895 participants between the ages of 1 year and 30 who have lymphoma. The following criteria must also be met: For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted, T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434, Patients shall have had"
Answered by AI
Does Daunorubicin Hydrochloride have the FDA's blessing?
"Daunorubicin Hydrochloride is considered safe according to our 3-point scale because it has reached Phase 3 in clinical trials. This signifies that, while more research is needed, there is already some evidence of its efficacy and it has undergone multiple rounds of testing for safety."
Answered by AI
Are there other ongoing or completed studies that have used Daunorubicin Hydrochloride?
"Daunorubicin Hydrochloride was first studied in 1997 at Spectrum Health Hospital - Butterworth Campus. As of now, there have been 4974 completed studies with 2306 more currently underway. The majority of these active studies are located in Hackensack, Indiana."
Answered by AI
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