Status:
COMPLETED
Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsors:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is a single arm Phase II, multicenter trial. It is designed to determine whether the anticipated endpoints for a T cell depleted transplant arm of a planned prospective randomized trial com...
Detailed Description
BACKGROUND: Allogeneic hematopoietic cell transplantation is an accepted therapy for AML. Transplants of unmodified HLA-matched related bone marrow or peripheral blood stem cells following conditioni...
Eligibility Criteria
Inclusion
- Patients with AML with or without prior history of myelodysplastic syndrome based on the World Health Organization criteria at the following stages:
- First morphologic complete remission (CR)
- Second morphologic CR
- If prior history of central nervous system (CNS) involvement, no evidence of active CNS leukemia during the pre-transplant evaluation (no evidence of leukemic blasts in cerebrospinal fluid)
- First or second CR was achieved after no more than two cycles of induction (or re-induction for patients in second CR) chemotherapy
- No more than 6 months elapsed from documentation of CR to transplant for patients in first CR, or 3 months for patients in second CR.
- A 6/6 HLA antigen (A, B, DRB1)-compatible sibling donor; the match may be determined at serologic level for HLA-A and HLA-B loci; DRB1 must be matched at least at low-resolution using DNA typing techniques; HLA-C will be typed at the serologic level, but not included in the match algorithm
- Karnofsky performance status greater than 70%
- Life expectancy greater than 8 weeks
- Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 40% (corrected for hemoglobin) with no symptomatic pulmonary disease
- Left ventricular ejection fraction (LVEF) by Multi Gated Acquisition Scan (MUGA) or echocardiogram greater than 40%
- Serum creatinine greater than 2 mg/dL, bilirubin greater than 2 mg/dL, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at least 3 times the upper limit of normal at time of enrollment
- Willingness of both the patient and the donor to participate
Exclusion
- M3-AML (acute promyelocytic leukemia) in first CR
- Acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
- M4Eo-AML with inv 16 in first CR
- AML with t(8;21) in first CR
- Participation in other clinical trials that involve investigational drugs or devices except with permission from the Medical Monitor
- Evidence of active Hepatitis B or C infection or evidence of cirrhosis
- HIV positive
- Uncontrolled diabetes mellitus
- If proven or probable invasive fungal infection, infection must be controlled; patients may be on prophylactic anti-fungal agents, but are not permitted to be on anti-fungal agents for therapeutic purposes (i.e., active treatment for disease)
- Uncontrolled viral or bacterial infection (currently taking medication without clinical improvement)
- Documented allergy to iron dextran or murine proteins
- Pregnant or breastfeeding; women of childbearing age must avoid becoming pregnant while in the study
- Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00201240
Start Date
June 1 2005
End Date
December 1 2013
Last Update
November 1 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Dana Farber Cancer Institute/Brigham & Women's Hospital
Boston, Massachusetts, United States, 02114
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021