Know Cancer

forgot password

A Phase I Study of B43-Genistein Immunoconjugate in Recurrent B-Lineage Acute Lymphoblastic Leukemia and Non Hodgkin's Lymphoma

Phase 1
80 Years
Open (Enrolling)
Leukemia, Lymphoma

Thank you

Trial Information

A Phase I Study of B43-Genistein Immunoconjugate in Recurrent B-Lineage Acute Lymphoblastic Leukemia and Non Hodgkin's Lymphoma

OBJECTIVES: I. Determine the maximum tolerated dose of B43-genistein immunoconjugate in
patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma. II.
Determine the systemic B43-genistein exposure levels in these patients. III. Determine the
antileukemic activity of this regimen in these patients. IV. Monitor the development of
human antimouse antibody in these patients on this regimen.

OUTLINE: This is a dose escalation study. Patients receive B43-genistein immunoconjugate IV
over 1 hour on days 1-3, 8-10, and 15-17. Treatment continues every 3 weeks in the absence
of unacceptable toxicity or until disease progression. Cohorts of 3-6 patients receive
escalating doses of B43-genistein immunoconjugate until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Patients are followed every 6 months.

PROJECTED ACCRUAL: A minimum of 3-15 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Immunophenotypically proven B-cell acute lymphoblastic leukemia
Relapsed at least once following standard induction chemotherapy M1, M2, M3 No CNS disease
(including clinical signs of CNS disease) OR Immunophenotypically proven B-cell
non-Hodgkin's lymphoma Refractory or resistant disease following up to 3 prior courses of
combination chemotherapy Relapsed following bone marrow transplantation No CNS disease No
AIDS-related or HTLV-1 associated lymphomas NHL must be one of the following types: Small
lymphocytic lymphoma (consistent with chronic lymphoblastic leukemia) Follicular small
cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma
Diffuse small cleaved cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell
lymphoma Immunoblastic large cell lymphoma Diffuse small noncleaved cell lymphoma Must
have greater than 20% CD19 antigen positive blasts in the bone marrow, peripheral blood,
or biopsy (for NHL) at first diagnosis or relapse (non-T cell ALL with CD19 positivity
pending allowed) Patients who have relapsed after bone marrow transplantation are eligible
(no active acute or chronic graft versus host disease involving more than the skin)

PATIENT CHARACTERISTICS: Age: 80 and under Performance status: Karnofsky 60-100% Zubrod
0-2 Life expectancy: At least 2 months Hematopoietic: Granulocytopenia, anemia, and/or
thrombocytopenia allowed Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) SGOT or SGPT less than 2.5 times ULN Renal: Creatinine no greater than 1.5
times ULN OR Creatinine clearance or radioisotope GFR at least 70 mL/min Cardiovascular:
Shortening fraction at least 27% by echocardiogram OR Cardiac ejection fraction greater
than 50% by echocardiogram or gaited radionuclide Pulmonary: No dyspnea at rest No
exercise intolerance No clinical evidence of significant restrictive pulmonary disease
Pulse oximetry greater than 94% FEV1 or FVC greater than 60% DLCO at least 65 Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for 2 months after study HIV negative No uncontrolled diabetes
mellitus No other serious uncontrolled medical condition No active uncontrolled infection
requiring systemic antibiotics or antifungal medications Prior CNS toxicity no greater
than grade 1

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Recovered from
prior biologic therapy Chemotherapy: See Disease Charactertistics At least 2 weeks since
prior chemotherapy (4 weeks since nitrosoureas) and recovered Endocrine therapy: At least
1 week since prior high dose steroid therapy and recovered Radiotherapy: Not specified
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Fatih M. Uckun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Parker Hughes Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood lymphoblastic lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's National Medical Center Washington, District of Columbia  20010-2970
Parker Hughes Institute St. Paul, Minnesota  55113