Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
NCT ID: NCT01385072
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2011-08-31
2015-04-30
Brief Summary
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Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.
The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Double matched sibling transplantation
Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.
Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
Double matched sibling transplantation
Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.
Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
Interventions
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Double matched sibling transplantation
Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.
Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS.
Eligibility Criteria
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Inclusion Criteria
2. Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
3. Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors:
AML- 2 or more of the following: duration of CR1 \< 6 months, poor cytogenetics, circulating blasts, karnofsky \< 90.
ALL- age \> 40 or second and additional relapse, or 2 or more of the following: BM blasts \> 25%, age 18-39,first refractory relapse, donor CMV positive.
4. Patients with 2 matched siblings and donor age \> 18 years old.
5. Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
6. Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.
Exclusion Criteria
2. Donor age \< 18 years.
3. Patients in remission or not fulfilling above disease criteria -
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Yeshurun, MD
Role: PRINCIPAL_INVESTIGATOR
Davidoff cancer center, Beilinson hospital, Rabin Medical Center
Locations
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Davidoff Cancer Center, Beilin hospital, Rabin medical center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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6188
Identifier Type: -
Identifier Source: org_study_id