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allogeneic stem cell transplant for Leukemia

Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post-registration
Awards & highlights

Study Summary

This trial is studying giving low doses of chemotherapy before a donor stem cell transplant to treat patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligible Conditions
  • Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post-registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post-registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2-year Progression-free Survival in Early Disease Participants
Secondary outcome measures
Acute Graft-vs-host Disease (GVHD)
Chimerism for CD3
Chronic GVHD
+3 more

Side effects data

From 2023 Phase 2 trial • 68 Patients • NCT01027000
88%
Platelet count decreased
86%
Neutrophil count decreased
81%
Anemia
68%
Hyperglycemia
61%
Creatinine increased
59%
Lymphocyte count decreased
58%
Fatigue
56%
Rash maculo-papular
56%
White blood cell decreased
49%
Nausea
47%
Diarrhea
44%
Alanine aminotransferase increased
44%
Hypocalcemia
42%
Aspartate aminotransferase increased
42%
Hypomagnesemia
42%
Hypertension
39%
Headache
37%
Cough
36%
Blood bilirubin increased
32%
Hypoalbuminemia
31%
Hyponatremia
29%
Fever
29%
Alkaline phosphatase increased
29%
Edema limbs
29%
Vomiting
25%
Dyspnea
25%
Back pain
24%
Tremor
24%
Hyperkalemia
24%
Hypertriglyceridemia
22%
Investigations - Other, specify
22%
Abdominal pain
22%
Hypokalemia
20%
Hypophosphatemia
19%
Pruritus
19%
Constipation
17%
Skin and subcutaneous tissue disorders - Other, specify
17%
Anorexia
15%
Infections and infestations - Other, specify
15%
Upper respiratory infection
15%
Mucositis oral
15%
Obesity
14%
Chills
14%
Insomnia
14%
Lung infection
14%
Cholesterol high
14%
Arthralgia
12%
Depression
12%
Activated partial thromboplastin time prolonged
12%
Sore throat
12%
Dizziness
12%
Anxiety
12%
Peripheral sensory neuropathy
12%
Lymphocyte count increased
12%
Weight loss
12%
Nasal congestion
12%
Hypernatremia
12%
Myalgia
10%
Febrile neutropenia
10%
Pneumonitis
10%
Dry mouth
10%
Dry eye
8%
Pain in extremity
8%
Dry skin
8%
Respiratory, thoracic and mediastinal disorders - Other, specify
8%
Eye disorders - Other, specify
8%
Edema face
8%
Hepatobiliary disorders - Other, specify
8%
Leukocytosis
8%
Hypotension
7%
Musculoskeletal and connective tissue disorder - Other, specify
7%
Pain
7%
Epistaxis
7%
Hypoxia
7%
Abdominal distension
7%
Sinus tachycardia
7%
Gastrointestinal disorders - Other, specify
7%
Hypermagnesemia
7%
Metabolism and nutrition disorders - Other, specify
7%
Arthritis
7%
Flank pain
7%
Generalized muscle weakness
7%
Hypoglycemia
7%
Skin hyperpigmentation
7%
Thromboembolic event
5%
Sinus pain
5%
Oral pain
5%
Urinary frequency
5%
Dysgeusia
5%
Neck pain
5%
Peripheral motor neuropathy
5%
Malaise
5%
Productive cough
5%
Cushingoid
5%
Blurred vision
5%
Dyspepsia
5%
Gastritis
5%
Pleural effusion
3%
Cystitis noninfective
3%
Hematuria
3%
Pleuritic pain
3%
Acute kidney injury
3%
Blood and lymphatic system disorders - Other, specify
3%
Sleep apnea
3%
Urinary tract infection
3%
Periorbital edema
3%
Libido decreased
3%
Neuralgia
3%
Fracture
3%
Infusion related reaction
3%
Nervous system disorders - Other, specify
3%
Hemorrhoids
3%
Aspiration
3%
Rectal pain
3%
Cholecystitis
3%
Allergic rhinitis
3%
Apnea
3%
Paresthesia
3%
Renal and urinary disorders - Other, specify
3%
Irritability
3%
Allergic reaction
3%
Mucosal infection
3%
Sepsis
3%
Sinusitis
3%
Catheter related infection
3%
Ascites
3%
Pharyngolaryngeal pain
3%
Postnasal drip
3%
Flushing
3%
Sinus bradycardia
3%
Non-cardiac chest pain
3%
Bone pain
3%
Intracranial hemorrhage
3%
Respiratory failure
3%
Skin ulceration
3%
Hot flashes
2%
Hemolysis
2%
Syncope
2%
Injection site reaction
2%
Osteoporosis
2%
Sinus disorder
2%
Chronic kidney disease
2%
Keratitis
2%
Edema cerebral
2%
Hallucinations
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Stomach pain
2%
Confusion
2%
Pain of skin
2%
Lethargy
2%
Glucose intolerance
2%
Stroke
2%
Papilledema
2%
Photophobia
2%
Pancreatitis
2%
Psychiatric disorders - Other, specify
2%
Urine discoloration
2%
Atelectasis
2%
Skin infection
2%
Vaginal infection
2%
Dysphasia
2%
Bruising
2%
Erythema multiforme
2%
Transient ischemic attacks
2%
Wheezing
2%
Alopecia
2%
Dysesthesia
2%
Hoarseness
2%
Toothache
2%
INR increased
2%
Ataxia
2%
Fall
2%
Delirium
2%
Erectile dysfunction
2%
Urinary urgency
2%
Bronchopleural fistula
2%
Genital edema
2%
Hepatic failure
2%
Eye pain
2%
Localized edema
2%
Neck edema
2%
Abdominal infection
2%
Bronchial infection
2%
Rhinitis infective
2%
Weight gain
2%
Scleral disorder
2%
Eye infection
2%
Hepatic infection
2%
Joint infection
2%
Lip infection
2%
Meningitis
2%
Colonic ulcer
2%
Dehydration
2%
Hypercalcemia
2%
Atrioventricular block first degree
2%
Palpitations
2%
Restrictive cardiomyopathy
2%
Supraventricular tachycardia
2%
Ear pain
2%
Tinnitus
2%
Endocrine disorders - Other, specify
2%
Cataract
2%
Corneal ulcer
2%
Dysphagia
2%
Enterocolitis
2%
Esophagitis
2%
Gastrointestinal pain
2%
Ileus
2%
Lip pain
2%
Malabsorption
2%
Agitation
2%
Abdominal soft tissue necrosis
2%
Chest wall pain
2%
Vertigo
2%
Hip fracture
2%
Intraoperative renal injury
2%
Hyperuricemia
2%
Skin hypopigmentation
2%
Urticaria
2%
Surgical and medical procedures - Other, specify
2%
Superficial thrombophlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Combination of Chemotherapy and Transplant)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Combination of chemotherapy and transplant)Experimental Treatment8 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
FDA approved
Fludarabine
FDA approved
Methotrexate
FDA approved
allogeneic stem cell transplant
2010
Completed Phase 2
~70
Cyclophosphamide
FDA approved
Sirolimus
FDA approved
Tacrolimus
FDA approved
Rituximab
FDA approved

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,570 Total Patients Enrolled
46 Trials studying Leukemia
33,505 Patients Enrolled for Leukemia
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,075 Total Patients Enrolled
54 Trials studying Leukemia
7,084 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,065 Total Patients Enrolled
1,513 Trials studying Leukemia
384,681 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the potential adverse effects associated with allogeneic stem cell transplant?

"Our team at Power rated allogeneic stem cell transplant a 2, as this Phase 2 trial has some safety data but none to support its effectiveness."

Answered by AI

What criteria must potential participants meet to qualify for this experiment?

"Eligible participants must have been diagnosed with leukemia and be aged between 18 to 69. Currently, the study is accepting 68 individuals in total."

Answered by AI

Is this trial open to senior citizens aged 70 and above?

"This clinical trial is only available to participants between 18 and 69 years old. There are 1042 studies for minors, while those over the age of 65 have access to 3604 alternative trials."

Answered by AI

Is there still an opportunity for individuals to enroll in this research?

"According to clinicaltrials.gov, this medical trial has concluded recruitment and is no longer accepting candidates; however, there are currently 4291 other studies actively searching for participants. Originally posted on February 1st 2010 and last edited August 16th 2021."

Answered by AI

How many individuals have elected to participate in this research endeavor?

"At this time, the trial is not seeking additional participants. It was first published on February 1st 2010 and recently updated on August 16th 2021. For those searching for other trials, there are 2,858 clinical studies regarding leukemia currently recruiting patients and 1,433 allogeneic stem cell transplants in need of volunteers."

Answered by AI

In what cases is allogeneic stem cell transplantation routinely recommended?

"Through the use of allogeneic stem cell transplant, patients can receive care for leukaemia, lung cancer and even small cell lung carcinoma (SCLC)."

Answered by AI

Have other clinical trials explored the efficacy of allogeneic stem cell transplantation?

"Presently, 1433 clinical trials are being conducted to investigate allogeneic stem cell transplant. Of these studies, 280 have progressed to Phase 3 of the research cycle. Most investigations for this treatment are located in Bethesda, Maryland; however, there is a total of 39844 sites running related experimentation."

Answered by AI

Are there a plethora of locations within the US currently testing this protocol?

"This trial is enrolling 25 participants and has sites located in Cleveland, Lewes, New york as well as various other locations. Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Cleveland Clinic Taussig Cancer Center, and Tunnell Cancer Center at Beebe Medical Cnetre are all part of this medical study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2010. "Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01027000.
~4 spots leftby Apr 2025
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