NCT01315132 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-03-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Overall Survival

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outcome · POSTED

Graft Versus Host Disease (GVHD)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Matched Sibling Allogeneic Transplantation
intervention Names
Device: Matched Sibling Allogeneic Transplantation
label
Allogeneic Transplantation
type
EXPERIMENTAL

interventions

arm Group Labels
Allogeneic Transplantation
description
Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
name
Matched Sibling Allogeneic Transplantation
other Names
CliniMACS
type
DEVICE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 47
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Patients With Overall Survival
time Frame
1 Year after transplant

secondary Outcomes

measure
Graft Versus Host Disease (GVHD)
time Frame
1 Year after transplant

Full study description

brief 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.
detailed 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.

Source references