Status:
COMPLETED
Improving Blood Stem Cell Collection and Transplant Procedures
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myelodysplastic Syndrome (MDS)
Chronic Myelogenous Leukemia
Eligibility:
All Genders
2-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- People who have some kinds of cancer can benefit from donated bone marrow stem cells. These stem cells help produce healthy bone marrow and slow or stop the spread of abnormal cells. H...
Detailed Description
Peripheral blood stem cell transplant research carried out by the NHLBI BMT Unit focus on transplant techniques designed to decrease graft versus host disease (GVHD), increase the graft-versus-leukemi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients in remission as well as patients with primary induction failure or refractory disease will be considered for inclusion. At the discretion of the PI, patients may continue standard of care treatment options to control their baseline disease burden up to the start of the protocol.
- RECIPIENT
- Ages 10-75 years inclusive
- Chronic myelogenous leukemia (CML):
- Subjects under the age of 21 in chronic phase
- Subjects ages 10-75 in chronic phase who have failed treatment with imatinib, have intolerance to imatinib, or who did not receive imatinib at therapeutic doses within the first 12 months from diagnosis.
- Subjects ages 10-75 in accelerated phase or blast transformation.
- Acute lymphoblastic leukemia (ALL): any of these categories: ALL in first remission with high-risk features (presenting leukocyte count \>100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia) All second or subsequent remissions, primary induction failure, partially responding or untreated relapse.
- Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse.
- Myelodysplastic syndromes(MDS): any of these categories - refractory anemia with transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes.
- Myeloproliferative disorders including atypical (Ph negative) chronic myeloid and neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential thrombocythemia in transformation to acute leukemia or with progressive transfusion requirements or pancytopenia.
- Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000/ micro-l) or anemia (less than or equal to 10g/dl) not due to recent chemotherapy.
- Non-Hodgkin s lymphoma including Mantle cell lymphoma relapsing or refractory to standard of care treatments.
- Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following standard of care treatments.
- HLA identical (6/6) related donor.
- For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: written informed consent from one parent or guardian. Informed oral consent from minors: the process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
- DONOR
- Related donor, HLA identical (6/6) with recipient
- Weight greater than or equal to 18 kg
- Age greater than or equal to 2 or less than or equal to 80 years old
- For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
- EXCLUSION CRITERIA:
- RECIPIENT (any of the following)
- Estimated probability of surviving less than three months
- Major anticipated illness or organ failure incompatible with survival from transplant
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and making informed consent impossible.
- Positive pregnancy test for women of childbearing age.
- HIV positive
- DLCO adjusted for Hb and ventilation \< 50% predicted
- Left ventricular ejection fraction \< 40% (evaluated by ECHO) or \< 30% (evaluated by MUGA)
- AST/SGOT \> 10 times ULN (\>grade 3, CTCAE)
- Bilirubin \> 5 times ULN (\>grade 3, CTCAE)
- Creatinine \> 4.5 times ULN (\>grade 3, CTCAE)
- Prior allogeneic stem cell transplantation
- DONOR (any of the following)
- Pregnant or breast-feeding. Lactating donors are permitted provided breastmilk is discarded during the days filgatrim (G-CSF) is given.
- Unfit to receive G-CSF and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension)
- Sickling hemaglobinopathy including HbSS, HbAS, HbSC
- Donors who are positive for HIV active hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II)
- Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
- Age greater than or equal to 80 years old
- Children who weigh less than or equal to 18 kg and are \< 2 years of age.
Exclusion
Key Trial Info
Start Date :
January 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01517035
Start Date
January 13 2012
End Date
March 29 2017
Last Update
July 5 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892