A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies

Multiple Myeloma Clinical Trial

Official title:

A Two Step Approach To Matched-Sibling Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematological Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315132
• Other study ID #: 08D.85
• Secondary ID: 2007-61
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2008
• Est. completion date: August 29, 2019

Study information

• Verified date: September 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.

Description:

This research protocol has been developed for patients undergoing matched-sibling hematopoietic stem cell transplant (HSCT). The patients who are treated according to this 2 step allogeneic HSCT protocol will receive cyclophosphamide to induce in-vivo tolerization of both autologous and allogeneic lymphocytes, followed by an allogeneic CD34-selected HSCT. The primary research questions relate to immune reconstitution, incidence of GVHD, and relapse in patients who receive lymphocyte treatment of this type in allogeneic HSCT and how it impacts overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 29, 2019
• Est. primary completion date: September 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:

1. Age > 50 years

2. ECOG Performance status of <2

3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR; second or greater CR, 1st relapse; any ph+ ALL

4. CML 2nd chronic phase, accelerated phase, or blastic phase

5. MDS with IPS of Intermediate 2 or greater

6. Any myeloproliferative disorder

7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure

8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT

9. Other conditions not listed will be assessed as high-risk by the PI

2. Patients must have a related donor who is either HLA-identical or a one antigen mismatch at the HLA- A; B; C; and DR loci.

3. Patients must adequate organ function:

1. LVEF of >45%

2. DLCO (adjusted for hemoglobin) >45% of predicted

3. Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X upper limit of normal

4. Creatinine clearance of > 60 ml/min

4. Patients must be willing to use contraception if they have childbearing potential

5. Able to give informed consent

Exclusion Criteria:

1. ECOG performance status of 3 or 4.

2. HIV positive

3. Active involvement of the central nervous system with malignancy

4. Psychiatric disorder that would preclude patients from signing an informed consent

5. Pregnancy

6. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.

Related Conditions & MeSH terms

• Hematological Malignancies
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Neoplasms

Intervention

Device:
• Matched Sibling Allogeneic Transplantation
Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Overall Survival	The primary objective of this prospective, phase II trial was to obtain an OS rate of >60% at 1 year in patients undergoing a 2 step HSCT from an HLA compatible family donor. The >60% threshold was selected as a composite efficacy measure as patients with any hematologic diagnosis, stage of disease, or age as old as 65 years were eligible for this treatment protocol.	1 Year after transplant
Secondary	Graft Versus Host Disease (GVHD)		1 Year after transplant

External Links

•   Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospitals