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Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation

Phase 2
Open (Enrolling)
Multiple Myeloma, Lymphocytic Leukemia, Chronic, Lymphoma, Low-Grade

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Trial Information

Phase II Trial of Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Reduced Intensity Allogeneic Stem Cell Transplantation

In this research study patients will receive dosages of chemotherapy that are lower than the
usual dosages. The study will determine whether a shorter duration of immunosuppression will
permit the donor cells to be effective against the cancer without causing more severe GVHD.
Also to be determined is whether the patient's cancer can be prevented from relapsing after
blood stem cell transplant by using prophylactic treatment, giving a donor leukocyte
infusion BEFORE a relapse happens.

In this research study samples of blood and bone marrow will be analyzed. These samples will
be examined to study the cellular production of inflammatory cytokine levels in attempt to
be able to predict which patients will have complications like GVHD or relapse.


Inclusion Criteria:

To be eligible a patient MUST meet at least one of the next 4 criteria

- Any patient aged 55 years or older with a hematological malignancy for which
allogeneic transplant is considered an appropriate treatment, AND/OR

- Any patient, regardless of age, with a hematologic malignancy for which allogeneic
transplant is considered an appropriate treatment and the patient is not eligible for
a conventional myeloablative transplant because of organ dysfunction AND/OR

- Any patient, regardless of age, who has relapsed following prior autologous or
allogeneic transplant for a hematologic malignancy AND/OR

- Any patient, regardless of age, with one of the following hematological malignancies:

1. Multiple myeloma

1. refractory to or failure following conventional chemotherapy such as VAD,
pulse decadron, or alkylating agents, or

2. chromosomal abnormality associated with poor prognosis by cytogenetics or
FISH probe.

2. Chronic lymphocytic leukemia patients, Rai stage 3 or 4 and relapsed
following/refractory to alkylating agents or nucleoside analog therapy

3. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or
follicular mixed small cleaved and large cell) that is either relapsed or
refractory provided the disease is NOT rapidly progressive, NOT bulky, and no
mass exceeds 5 cm in greatest dimension.

To be eligible a patient MUST meet all of the following criteria

- In addition to the above criteria ALL patients must meet the following minimum organ

1. Cardiac: Ejection fraction at least 30%.

2. Renal: Adequate renal function as defined by creatinine < 2.0mg OR creatinine
clearance >40 mg/min by 24-hour urine collection or GFR. (Gender and
age-adjusted creatinine clearance >40ml/min by Gault-Cockroft55 is acceptable
for adults: (140 - age) x weight/72 x Scr [x 0.85 if female]).

3. Pulmonary: FEV1 and FVC >60%.

4. Hepatic: Total bilirubin <2.0 and AST/ALT < 3X institutional normal for age.

5. Performance (adults): Karnofsky score must be at least 60; for pts. under 16,
Lansky score must be at least 60.

- Availability of a 5/6 or 6/6 HLA A, B, and DR identical relative who is willing and
able to donate allogeneic stem cells. Serological, low resolution or mid resolution
molecular typing will determine the degree of match for HLA class I regardless of
high resolution DNA typing results. High resolution typing will be used to determine
the degree of match for HLA-DR.

- No untreated or uncontrolled invasive infections. Patients still under therapy for
presumed or proven infection are eligible provided there is clear evidence
(radiologic and/or culture) that the infection is well controlled. Patients under
treatment for infection will be enrolled only after clearance from the Principal

- Not pregnant

Patient Exclusion Criteria:

- acute leukemia

- HIV positive patients not eligible

- Any physical or psychological condition that, in the opinion of the investigator,
would pose unacceptable risk to the patient

- Pregnant


Inclusion Criteria:

- 5/6 or 6/6 HLA match for HLA-A, B, and DR

- Age 3-70 years, good general health

- No contraindication to G-CSF stimulation

- No contraindication to leukapheresis of peripheral blood stem cells

- Good general health

Donor Exclusion Criteria:

- HIV positive or history of HIV risk factors

- Presence of other diseases transmissible by blood that pose unacceptable risk to the
study subject.

- Pregnant

- Medical or psychological conditions that would make the donor unlikely to tolerate
G-CSF - injections or leukapheresis

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:

To establish the rate of acute GVHD following prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

John E. Levine, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Univeristy of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2-61



Start Date:

April 2003

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Lymphocytic Leukemia, Chronic
  • Lymphoma, Low-Grade
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, Non-Hodgkin
  • Chronic Disease



The University of Michigan Ann Arbor, Michigan  48109