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

Phase 1

• Conditions: Relapsed and Refractory Acute Leukemia
• Interventions: Biological: Double matched sibling transplantation

• Registration Number: NCT01385072
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Study Start: 2011-08
• Last Update Submitted: 2011-11-14
• Last Update Posted: 2011-11-16
• Primary Completion: 2014-08
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double matched sibling transplantation	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.

Primary Outcome Measures

Name	Time	Method
Acute graft versus host disease rate,severity and response to treatment	100 days

Secondary Outcome Measures

Name	Time	Method
relapse rate	12 months

Trial Locations

Locations (1)

Davidoff Cancer Center, Beilin hospital, Rabin medical center; 🇮🇱 Petach Tikva, Israel