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Anti-metabolites
Thiotepa + Fludarabine + Melphalan for Leukemia
Phase 2
Waitlist Available
Led By Leland Metheny, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with specific hematologic malignancies including AML, ALL, MDS, Mixed Phenotypic Leukemia, CML, Myelofibrosis, and Relapsed or Refractory Lymphoid Malignancies
Patients with specific HLA matching criteria or a related haplo-identical donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after transplant
Awards & highlights
Study Summary
This trial will investigate whether combining thiotepa with melphalan and fludarabine is a safe and effective reduced intensity conditioning regimen for alternative donor transplants.
Who is the study for?
This trial is for patients with certain blood cancers like leukemia, myelodysplasia, or lymphoma who don't have a matched donor. They should be in remission or have minimal disease after treatment and must not be pregnant. Participants need to be fairly active (ECOG ≤ 2) and able to understand the study.Check my eligibility
What is being tested?
The trial tests a combination of Thiotepa, Melphalan, and Fludarabine as pre-treatment before receiving stem cells from alternative donors like umbilical cord blood or half-matched relatives. It aims to see if this regimen is safe/effective for high-risk patients without standard donors.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, mouth sores (mucositis), low blood counts leading to infection risk, liver problems (elevated bilirubin/AST/ALT), kidney issues (reduced creatinine clearance), lung function decrease (DLCOc <60%), and heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific blood cancer such as AML, ALL, or CML.
Select...
I have a donor who is a perfect match or nearly matches my genetic makeup.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year after transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with leukemia free survival
Secondary outcome measures
Average overall survival
Incidence of acute GVHD
Incidence of chronic GVHD
+4 moreSide effects data
From 2022 Phase 3 trial • 665 Patients • NCT0056756784%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
57600-Nausea
3%
65900-Pleural effusion
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
66300-Pneumonitis
1%
42600-Hypoalbuminemia
1%
26600-Duodenal obstruction
1%
69700-Rash maculo-papular
1%
23000-Confusion
1%
71500-Respiratory failure
1%
34000-Fibrinogen decreased
1%
45800-INR increased
1%
73900-Serum amylase increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned
Trial Design
1Treatment groups
Experimental Treatment
Group I: Thiotepa + Fludarabine + MelphalanExperimental Treatment3 Interventions
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Thiotepa
2008
Completed Phase 3
~2150
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,870 Total Patients Enrolled
34 Trials studying Leukemia
1,619 Patients Enrolled for Leukemia
Leland Metheny, MDPrincipal InvestigatorCase Comprehensive Cancer Center
7 Previous Clinical Trials
106 Total Patients Enrolled
2 Trials studying Leukemia
50 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific blood cancer such as AML, ALL, or CML.I can understand and sign a consent form.My condition meets specific health and activity level criteria.I have a donor who is a perfect match or nearly matches my genetic makeup.My organ functions, including kidney, liver, lung, heart, and overall health status, meet the required levels.I am eligible for treatment targeting leukemia outside the bone marrow or lymphoma in the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Thiotepa + Fludarabine + Melphalan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does this trial include those aged 40 and above?
"Prospective participants must meet the specified age range of 1 year to 65 years old as outlined in this trial's inclusion criteria."
Answered by AI
How many participants are engaged in the experiment?
"Affirmative. Clinicaltrials.gov records that since its initial posting on March 21st, 2018 this medical trial is still searching for recruits. A total of 39 individuals must be recruited from a single site before the study can conclude."
Answered by AI
What risk factors should be considered before administering Thiotepa?
"The safety of Thiotepa was scored a 2 out of 3, seeing as there is preliminary evidence on its security but no prior data supporting efficacy."
Answered by AI
Has recruitment begun for this investigation yet?
"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants and was first posted on March 21st 2018 before being updated most recently in November 18th 2022. A total of 39 people are needed at one medical facility for the study."
Answered by AI
Could I be considered a participant in this research project?
"Submitting 39 participants, this clinical trial seeks individuals between 1 year and 65 years of age afflicted with leukemia. To be eligible for consideration, candidates must fulfill the following criteria: antecedent hematological illness (e.g., myelodysplasia), leukaemia originating from prior treatments, complete remission one featuring poor-risk cytogenetics or molecular markers (Flt 3 mutation/11q23/del 5/7), second or third full recovery, induction failure with marrow blasts less than 10%, acute lymphoblastic leukaemia presenting poor-risk chromosomal features (t(9;22)or 11"
Answered by AI
What medical applications is Thiotepa routinely used to treat?
"Thiotepa is well-known for its curative effects on amyloidosis, but it can also be deployed to treat multiple myeloma and malignant effusion of the urinary bladder."
Answered by AI
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