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

Phase 2
18 Years
Open (Enrolling)
Hematologic Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Hodgkin's Disease

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

1 Year

Safety Issue:


Principal Investigator

Neal Flomenberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

April 2015

Related Keywords:

  • Hematologic Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Hodgkin's Disease
  • Myeloablative Hematopoietic Stem Cell Transplant
  • Cyclophosphamide tolerization
  • 2 Step Approach
  • Hematological malignancies
  • leukemia
  • lymphoma
  • multiple myeloma
  • Hodgkin's Disease
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms



Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541