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

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.

Study Overview

• Status: Unknown
• Conditions: Relapsed and Refractory Acute Leukemia
• Intervention / Treatment: Biological: Double matched sibling transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Moshe Yeshurun, MD; Phone Number: 972-9378127; Email: moshey@clalit.org.il
• Study Contact Backup: Name: Ron Ram, MD; Phone Number: 972-9378116; Email: RonRa@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Davidoff Cancer Center, Beilin hospital, Rabin medical center
    • Principal Investigator: Moshe Yeshurun, MD
    • Contact: Moshe Yeshurun, MD; Phone Number: 972-3-9378127; Email: moshey@clalit.org.il
    • Contact: Ron Ram, MD; Phone Number: 972-3-9378116; Email: RonRa@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute graft versus host disease rate,severity and response to treatment	100 days

Secondary Outcome Measures

Outcome Measure	Time Frame
relapse rate	12 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Moshe Yeshurun, MD, Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 28, 2011
• First Posted (Estimate): June 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 14, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: relapse; allogeneic transplantation; acute leukemia; induction failure; graft versus leukemia effect
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Leukemia; Acute Disease
• Other Study ID Numbers: 6188