Stem Cell Transplantation for Patients With Cancers of the Blood

Completed · Phase 2

Conditions studied: CML (Chronic Myelogenous Leukemia), CLL (Chronic Lymphocytic Leukemia), AML (Acute Myelogenous Leukemia), Acute Lymphocytic Leukemia, MDS (Myelodysplastic Syndrome)

In brief

This study will try to improve the safety and effectiveness of stem cell transplant procedures in patients with cancers of the blood. It will use a special machine to separate immune cells (T cells) from the blood of both the donor and the patient and will use photodepletion, a laboratory procedure that selectively kills cancer cells exposed to light. These special procedures may reduce the risk of graft-versus-host-disease (GVHD), a serious complication of stem cell transplants in which the donor's immune cells destroy the patient's healthy tissues, and at the same time may permit a greater graft-versus-leukemia effect, in which the donated cells fight any residual tumor cells that might remain in the body. Patients between 18 and 75 years of age with a life-threatening disease of the bone marrow (acute or chronic leukemia, myelodysplastic syndrome, or myeloproliferative syndrome) may be eligible for this study. Candidates must have a family member who is a suitable tissue match.

Key facts

Study ID: NCT00467961
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 61
Starts: 2007-04-01
Expected to finish: 2012-11-01
Last updated by the study team: 2018-07-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Recipient Criteria:
Diagnosed with one of the following hematological conditions:
Chronic myelogenous leukemia (CML): 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; accelerated phase or blast transformation.
Acute B-lymphoblastic leukemia (B-ALL): any of these categories: B-ALL in first remission with high-risk features (presenting leukocyte count greater than 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 /microl) 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.
Ages 18-75 years inclusive.
HLA identical (6/6) related donor.
Ability to comprehend the investigational nature of the study and provide informed consent.
Donor Criteria:
Related 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.

You may not qualify if…

Recipient Criteria (any of the following):
Malignant cells expressing a T cell phenotype (in particular T-ALL and T cell NHL).
DLCO less than 65 percent predicted.
Left ventricular ejection fraction less than 40 percent (evaluated by ECHO) or less than 30 percent (evaluated by MUGA).
AST/SGOT greater than 10 times ULN (CTCAE grade IV v3.0).
Bilirubin greater than 5 times ULN (CTCAE grade IV v3.0).
Creatinine greater than 4.5 times ULN (CTCAE grade IV v 3.0).
HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-1/II) are not excluded from participation).
Positive pregnancy test for women of childbearing age.
Prior allogeneic stem cell transplantation.
Estimated probability of surviving less than three months.
Major anticipated illness or organ failure incompatible with survival from transplant.
Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
Donor Criteria (any of the following):
Pregnant or lactating.
Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history of stroke, uncontrolled hypertension).
Sickling hemoglobinopathies including HbSS, HbAS, HbSC.
HIV positive Donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) will be used at the discretion of the investigator following counseling and approval from the recipient.
Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the donation of stem cells unlikely and informed consent impossible.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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