Post Transplant Donor Lymphocyte Infusion

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00167180
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Masonic Cancer Center, University of Minnesota
• Public title: Post Transplant Donor Lymphocyte Infusion
• Scientific title: Use of Cyclophosphamide/Fludarabine to Promote in Vivo Expansion of Donor Lymphocyte Infusions (DLI) to Enhance Efficacy After Allogeneic Transplant
• Date of first enrolment: January 2004
• Target sample size: 57
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00167180
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jeffrey Miller, MD
• Affiliation: Masonic Cancer Center, University of Minnesota

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients (age > or = 1 years) with a diagnosis of relapse after related or unrelated
allogeneic stem cell transplantation for a hematological malignancy.

- For CML, relapse will be defined as any cytogenetic evidence of a Philadelphia
chromosome or persistence of BCR/ABL rearrangements by molecular testing on at least
two measurements over a 6 month interval. If cytogenetics are normal and there is PCR
evidence of a BCR/ABL fusion, patients will be eligible if they have evidence of a
quantitative increase in CML measured either by quantitative PCR or by fluorescent in
situ hybridization (FISH).

- For non-CML, relapse will be defined based on disease specific morphologic criteria
from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics.
For disease specific definition of relapse, see appendix 3. Relapse can be determined
morphologically with less than 5 percent blasts if definitive relapse can be
determined. Equivocal results for relapse should result in a repeated test after an
appropriate time interval (suggested 1 month) to determine eligibility.

Post-transplant lymphoproliferative diseases (often referred to as EBV-associated
lymphomas) are NOT eligible for this protocol.

- For Chronic Phase CML patients only

- - must have failed (no response in 3 months or incomplete response at 6 months) or
refused treatment with Gleevec

- - if no prior DLI, CML patients will first have DLI- if relapse occurs after DLI, DLI
with chemotherapy per this protocol will be offered

- Patients must be within one year of identification of relapse or if beyond that time
period, must have at least 10% donor DNA by RFLP or cytogenetics.

- Same allogeneic donor (sibling or URD) used for transplantation is available for
lymphocyte donation.

- No severe organ damage (by laboratory or clinical assessment) as measured by:

- - blood creatinine = 2.0 mg/dL

- - liver function tests < 5 x normal

- - left ventricular ejection fraction > 40% (testing required only if symptomatic or
prior known impairment).

- - pulmonary functions > 50% (testing required only if symptomatic or prior known
impairment). Oxygen saturation (>92%) can be used in child where PFT's cannot be
obtained.

- - chest x-ray without evidence of active infection

- Off prednisone and other immunosuppressive agents (given for any reason) for at least
3 days prior to DLI infusions.

- Performance status = 60%

- Women must not be pregnant or lactating. The agents used in this study may be
teratogenic to a fetus and there is no information on the excretion of agents into
breast milk All females of childbearing potential must have a blood test or urine
study within 2 weeks prior to registration to rule out pregnancy

- Women of childbearing potential and sexually active males are strongly advised to use
an accepted and effective method of contraception

- Patient must given written informed consent indicating understanding of the nature of
the treatment and its potential risks

Exclusion Criteria:

- Concurrent signs of acute or chronic graft-versus-host disease requiring ongoing
treatment at the time of relapse will be ineligible.

- Patients being treated for GVHD with prednisone, cyclosporine, Imuran or other
immunosuppressive medications are not eligible until these medications are
discontinued for at least 2 weeks without a flare of GVHD.

- Active CNS leukemia

- Active fungal infection or pulmonary infiltrates (stable prior treated disease is
allowable)

- HIV positive



Age minimum: 1 Year
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Leukemia, Lymphocytic, Chronic

Myelodysplastic Syndrome

Leukemia, Lymphocytic, Acute

Lymphomas

Leukemia, Myeloid, Chronic

AML

Intervention(s)

Drug: Induction Chemotherapy

Procedure: Donor Lymphocyte Infusion

Primary Outcome(s)

Number of Patients Alive [Time Frame: 1 Year]

Secondary Outcome(s)

Number of Participants With Complete Remission [Time Frame: one year]

Number of Patients With Bone Marrow Aplasia [Time Frame: Day 100]

Number of Patients Alive Without Disease [Time Frame: 1 Year]

Number of Patients With Acute Graft-Versus-Host Disease [Time Frame: Day 100]

Secondary ID(s)

0401M55207

2004LS006

MT2003-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00167180