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NCT01385072 Clinical Trial

Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies

Relapsed and Refractory Acute Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01385072
Other study ID # 6188
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received June 28, 2011
Last updated November 14, 2011
Start date August 2011
Est. completion date April 2015

Study information
Verified date June 2011
Source Rabin Medical Center
Contact Moshe Yeshurun, MD
Phone 972-9378127
Email moshey@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date April 2015
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age 18 years or older

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:

1. Patient age < 18 years.

2. Donor age < 18 years.

3. Patients in remission or not fulfilling above disease criteria -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel Davidoff Cancer Center, Beilin hospital, Rabin medical center Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute graft versus host disease rate,severity and response to treatment 100 days Yes
Secondary relapse rate 12 months No