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Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning

Phase 2
Not Enrolling
Leukemia, Lymphoma, Low-Grade, Lymphoma, Non-Hodgkin's, Multiple Myeloma, Myelodysplastic Syndromes

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Trial Information

Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning

This research project will focus on whether it is safe and effective to rely on donor cells
to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell
transplant (SCT). For many patients with these conditions, a bone marrow transplant can be
the only chance for cure. The standard type of bone marrow transplant involves giving very
high-doses of chemotherapy and radiation to kill all the cancer cells followed by an
infusion of bone marrow stem cells from a relative who is a bone marrow match. After the
transplant the patient takes anti-rejection drugs for many months to prevent the donor’s
immune cells from causing a severe reaction called Graft-versus-Host Disease (GVHD), which
can even be fatal. However, for some patients with certain types of high-risk cancer even
this intense treatment is not effective and the cancer relapses.

Is has been known for many years that some of the bone marrow cells from the donor can kill
cancer cells. Recently, it has been discovered that sometimes patients who relapse after a
bone marrow SCT can be cured by giving an infusion of donor white blood cells (called a
donor leukocyte infusion or DLI). By giving a DLI BEFORE a relapse happens, hopefully
relapse can be prevented.

The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow
stem cell transplant can make a patient very sick and also increase the chance of getting
severe GVHD. In this research study we are going to rely mainly on the donor cells to kill
the cancer cells, and patients will receive dosages of chemotherapy that are lower than the
usual dosages. It is thought that this low intensity conditioning will make the transplant
safer without risking more relapses, however it is not know whether low intensity
conditioning is safer than standard conditioning.


Inclusion Criteria:

- One of the following hematological malignancies:

1. Chronic myelogenous leukemia

1. Accelerated phase

2. Blast phase

2. Acute myelogenous leukemia

1. First or greater complete remission if high risk features: abnormalities of
chromosomes with known poor prognosis 5 or 7.

2. Relapsed or refractory patients with ≤ 30% blasts

3. Aged 55 years or older in any disease state beyond first remission if blast
percentage is < 30%.

3. Acute lymphoblastic leukemia

1. First complete remission if high risk features: t(4;11)

2. Second complete remission if relapse occurs within the first 12 months of

3. Third or greater complete remission

4. Relapsed or refractory patients with ≤ 30% blasts

5. Aged 55 years or old in second in any disease state beyond first remission
if blast percentage is < 30%.

4. Myelodyplastic syndromes

1. RAEB or RAEB-t patients, 55 years of age or older

2. Any hematologic malignancy relapsed following autologous or matched related
donor allogeneic stem cell transplant provided at least 90 days has elapsed
from most recent transplant

5. Non-Hodgkin’s Lymphoma

1. 55 years or older, who have failed anthracycline containing regimen and do
not have any tumor larger than 5 cm in diameter.

2. Patients with rapidly progressive disease are ineligible.

6. Multiple myeloma patients, any age, who meet at least one of the following

1. disease refractory to conventional chemotherapy such as VAD, pulse
decadron, or alkylating agents, OR

2. chromosomal abnormality by cytogenetics or FISH probe.

7. Chronic lymphoblastic leukemia patients

1. Any age

2. Advanced disease (Rai stage 3 or 4)

3. Relapsed following/refractory to alkylating agents or nucleoside analog

4. NOTE: Patients with bulky disease (lymphadenopathy > 5 cm) or progressive
disease NOT eligible.

8. Mantle cell lymphoma

1. Any age

2. Disease stage 3 or 4

3. Lymphadenopathy must not exceed 5 cm in any dimension

9. Any eligible disease category, any age, if ineligible for myeloablative
conditioning because of organ dysfunction or advanced age (55 years or older).
Minimum organ function for patients entered on this protocol defined as:

1. Cardiac: Ejection fraction at least 30%.

2. Renal: Creatinine <1.5 times normal for age.

3. Pulmonary: FEV1 and FVC >60%.

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

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

10. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or
follicular mixed small cleaved and large cell) must meet the following criteria:

1. any age

2. relapsed or refractory disease provided the disease is NOT rapidly

3. no lymphoma mass or lymph node exceeds 5 cm in greatest dimension

- Age: no age restriction

- Availability of a 6/6 HLA A, B, and DR identical relative who is willing and able to
donate allogeneic stem cells

- No active infection

- Serum creatinine less than 1.5 times normal for age

- Serum bilirubin less than 1.5 times normal for age

- Not pregnant.

Patient Exclusion Criteria:

- HIV positive patients not eligible

- Pregnant


Inclusion Criteria:

- 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: Educational/Counseling/Training

Outcome Measure:

To conduct a phase I-II trial of prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies

Principal Investigator

John E. Levine, MS MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Univeristy of Michigan


United States: Institutional Review Board

Study ID:

UMCC 9979



Start Date:

March 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma, Low-Grade
  • Lymphoma, Non-Hodgkin's
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia



The University of Michigan Ann Arbor, Michigan  48109