Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

White Blood Cells in Treating Patients With Recurrent or Persistent Hematologic Cancers

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	65 and under	NCI	RPCI-RP-9807 UTSMC-GVT-092-136, NCI-G98-1490

Objectives

I.  Assess the response rates and graft versus host disease using donor 
leukocyte infusions (DLI) in patients with relapsed or persistent acute 
myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndrome, 
multiple myeloma, non-Hodgkin's lymphoma, or Hodgkin's disease.

II.  Assess response rates in the patients with minimal disease either because 
of molecular- or cytogenetic-only relapse or because DLI given in nadir-period 
postchemotherapy.

III.  Assess response rates and graft versus host disease in patients given 
lower cell doses (either early relapse of chronic myelogenous leukemia or 
mismatched family or unrelated donors).

IV.  Assess the efficacy of concurrent donor hematopoietic stem cells infused 
with DLI in abrogating pancytopenia in patients with low percentage donor 
chimerism at the time of treatment.

V.  Assess the predictive value of various recipient malignant cell phenotypic 
features in predicting response in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed relapsed or persistent hematologic malignancy
 Chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), acute
  lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS), multiple myeloma
  (MM), non-Hodgkin's lymphoma (NHL), or Hodgkin's disease (HD)

CML
 - Molecular relapse (molecular relapse is not treated if the donor was an
    unrelated donor)
     Bone marrow transplantation (BMT) was T cell depleted and bcr/abl
      detectable by 2 consecutive PCR determinations greater than 30 days
      apart at any time after day 100 postallogeneic stem cell transplant
     BMT was non-T cell depleted, a negative bcr/abl by PCR has been
      documented postallogeneic stem cell transplant and bcr/abl is now
      detectable by 2 consecutive PCR determinations greater than 30 days
      apart
     BMT was non-T cell depleted and bcr/abl is detectable by PCR
      determination at any time after day 180 postallogeneic stem cell
      transplant OR
 - Cytogenetic relapse OR
 - Relapse with chronic phase, accelerated phase, or blastic phase disease

AML, ALL, or MDS
 - Molecular relapse (less than 5% blasts)
    Leukemia-specific molecular abnormality is detectable by PCR analysis,
     provided a previous posttransplant PCR analysis has been negative OR
 - Cytogenetic relapse (less than 5% blasts)
    Leukemia-specific chromosome abnormality detectable by standard
     cytogenetics at any time greater than day 50 posttransplant OR
 - Hematologic relapse

MM
 - Relapse
    Recurrence of M-protein after previous posttransplant documentation of
     disappearance of M-protein by immunofixation OR
 - Residual disease
    Rising M-protein level at any time posttransplant
    M-protein detectable at 6 months posttransplant OR
 - IEP is required to show that M-component is the same as pretransplant

NHL or HD
 - Relapse
    Clearcut growth of disease by serial physical exam, radiographic studies,
     or molecular studies is required to define relapse

No active acute or chronic graft versus host disease

Original bone marrow donor available for lymphocyte donation

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Prior steroids must be tapered off over 1-4 weeks as clinically indicated
 No concurrent steroids

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 At least 4 weeks since any prior immunosuppressive therapy

Patient Characteristics:

Age:
 65 and under

Performance status:
 Not specified

Life expectancy:
 At least 4 weeks

Hematopoietic:
 Platelet count at least 20,000/mm3

Hepatic:
 Not specified

Renal:
 Creatinine no greater than 2.5 mg/dL

Other:
 HIV negative
 Not pregnant or nursing

Expected Enrollment

There will be 210-530 patients accrued into this study over 3 years.

Outline

This is a multicenter study.

Patients receive donor leukocyte infusion (DLI) over 30-60 minutes without 
pre-DLI chemotherapy, 10-14 days after beginning of chemotherapy, or after 
recovery from chemotherapy.  

Patients with chronic myelogenous leukemia (CML) at accelerated phase or blast 
phase receive either cytarabine/daunorubicin, 
vincristine/prednisone/daunorubicin, or another chemotherapy regimen at the 
physician's discretion prior to DLI.  Patients with acute myeloid leukemia 
(AML) or myelodysplastic syndrome (MDS) at hematologic relapse receive 
cytarabine/daunorubicin or another chemotherapy regimen at the physician's 
discretion prior to DLI.  Patients with acute lymphocytic leukemia (ALL) at 
hematologic relapse receive vincristine/prednisone/daunorubicin or another 
chemotherapy regimen at the physician's discretion prior to DLI.  Patients 
with non-Hodgkin's lymphoma (NHL) receive 
cyclophosphamide/doxorubicin/prednisone/vincristine, and patients with 
Hodgkin's disease (HD) receive bleomycin/dacarbazine/doxorubicin/vinblastine 
or another chemotherapy regimen at the physician's discretion prior to DLI. 

Patients with persistent disease after the initial DLI (16 weeks from CML in 
molecular, cytogenic, or chronic phase relapse, 12 weeks for multiple myeloma, 
4 weeks for AML, ALL, MDS, NHL, HD who have not developed graft versus host 
disease or disease response after the initial DLI) are eligible for a second 
DLI.

Patients are followed monthly for 3 months, then every 3 months for 9 months, 
then every 6 months for 2 years, and then annually thereafter. 

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Philip McCarthy, MD, Protocol chair		Ph: 716-845-4074; 800-685-6825 Email: philip.mccarthy@roswellpark.org