Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
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Purpose
Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed and Refractory Acute Leukemia |
Biological: Double matched sibling transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies |
- Acute graft versus host disease rate,severity and response to treatment [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- relapse rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Biological: 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years or older
- Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
-
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.
- Patients with 2 matched siblings and donor age > 18 years old.
- Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
- Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.
Exclusion Criteria:
- Patient age < 18 years.
- Donor age < 18 years.
- Patients in remission or not fulfilling above disease criteria -
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01385072
| Contact: Moshe Yeshurun, MD | 972-9378127 | moshey@clalit.org.il | |
| Contact: Ron Ram, MD | 972-9378116 | RonRa@clalit.org.il |
| Israel | |
| Davidoff Cancer Center, Beilin hospital, Rabin medical center | Recruiting |
| Petach Tikva, Israel | |
| Contact: Moshe Yeshurun, MD 972-3-9378127 moshey@clalit.org.il | |
| Contact: Ron Ram, MD 972-3-9378116 RonRa@clalit.org.il | |
| Principal Investigator: Moshe Yeshurun, MD | |
| Principal Investigator: | Moshe Yeshurun, MD | Davidoff cancer center, Beilinson hospital, Rabin Medical Center |
More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01385072 History of Changes |
| Other Study ID Numbers: | 6188 |
| Study First Received: | June 28, 2011 |
| Last Updated: | November 14, 2011 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Rabin Medical Center:
|
acute leukemia relapse induction failure allogeneic transplantation graft versus leukemia effect |
Additional relevant MeSH terms:
|
Acute Disease Leukemia Disease Attributes |
Neoplasms Neoplasms by Histologic Type Pathologic Processes |
ClinicalTrials.gov processed this record on March 03, 2015