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Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma

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Trial Information

Phase II Study Of Iodine-131 Anti-B1 Antibody Plus CHOP For Patients With Previously Untreated Mantle Cell Lymphoma


The primary efficacy endpoint of this study is to determine the duration of response of the
sequential administration of Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP for
patients with previously untreated MCL. The secondary efficacy endpoints for this study are
to determine the response rate, confirmed response rate, complete response rate, confirmed
complete response rate, duration of response for confirmed responders, duration of response
for complete responders, duration of response for confirmed complete responders,
progression-free survival, time to treatment failure, and the predictive value of detection
of minimal residual disease by molecular techniques on response duration. The
pharmacokinetic endpoint is to determine the total body residence time of Iodine-131 Anti-B1
Antibody following the dosimetric dose. The safety endpoints are to determine the incidence
of adverse experiences, hematologic toxicity, (e.g., nadir, time to nadir, and time to
recovery), use of supportive care, percent of patients converting to human anti-murine
antibody (HAMA) positivity, the effects of Iodine-131 Anti-B1 Antibody on the growth and
function of hematopoietic progenitor cells, and survival of patients with previously
untreated MCL treated with Iodine-131 Anti-B1 Antibody followed by six cycles of CHOP.


Inclusion Criteria:



- Patients must have a confirmed initial diagnosis of mantle cell non-Hodgkin's
lymphoma by histology according to the WHO classification .

- Patients must have Ann Arbor bulky stage II, stage III, or stage IV disease at
diagnosis. Bulky stage II disease is defined as a mediastinal mass greater than
one-third of the maximum chest diameter, or any other mass greater than or equal to
10 cm in maximum diameter.

- Patients must have less than an average of 25% of the intratrabecular marrow space
involved by NHL in bilateral bone marrow biopsy specimens as assessed microscopically
at study entry. A unilateral bone marrow biopsy demonstrating <10% involvement with
NHL is also adequate.

- Patients must have evidence that their tumor tissue expresses the CD20 antigen.
Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with
L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity
with Anti-B1 Antibody (Coulter Clone) or similar commercially available CD20 antibody
or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20
positivity. This must be performed within 42 days of study entry.

- Patients must have a performance status of at least 60% on the Karnofsky Performance
Scale and an anticipated survival of at least 3 months.

- Patients must have an ANC greater than or equal to 1500 cells/mm3 and a platelet
count greater than or equal to 100,000 cells/mm3 within 14 days of study enrollment.
These blood counts must be sustained without support of hematopoietic cytokines or
transfusion of blood products.

- Patients must have adequate renal function (defined as serum creatinine <1.5 times
the upper limit of normal) and hepatic function (defined as total bilirubin <1.5
times the upper limit of normal and AST <5 times the upper limit of normal) within 14
days of study enrollment.

- Patients must have bi-dimensionally measurable disease. At least one lesion must be
greater than or equal to 2.0 x 2.0 cm by computerized tomography scan.

- Females of childbearing potential must have a negative serum pregnancy test within 7
days prior to study enrollment.

- Patients must have a cardiac left ventricular ejection fraction of greater than or
equal to 50% by ventriculography or echocardiogram.

Exclusion Criteria:

- Patients who have received prior chemotherapy, biologic therapy, steroids, or
radiation therapy as treatment for their MCL

- Patients with active obstructive hydronephrosis

- Patients with serious illness that would preclude evaluation

- Patients with prior malignancy other than lymphoma, except for adequately treated
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease free for 5 years

- Patients with known HIV infection

- Patients who are HAMA positive

- Patients with known brain or leptomeningeal metastases.

- Patients who are pregnant or breastfeeding. Males and females must agree to use a
contraceptive method while on study and for 6 months after receiving Iodine-131
Anti-B1 Antibody.

- Patients with active infection requiring IV anti-infectives at the time of study
enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CP-99-037

NCT ID:

NCT00022945

Start Date:

Completion Date:

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle Cell Lymphoma
  • Radioimmunotherapy
  • Monoclonal Antibody
  • Corixa
  • Bexxar
  • Anti-B1 Antibody
  • Tositumomab
  • Iodine -131 Anti-B1 Antibody
  • Iodine I 131 Tositumomab
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Rush-Presbyterian-St. Lukes Medical CenterChicago, Illinois  60612
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104