Study Evaluating The Safety And Tolerability Of Combination Therapy Inotuzumab Ozogamicin (CMC-544) And Rituximab

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-04

Study Completion Date

2010-03-10

Brief Summary

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To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).

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Detailed Description

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Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inotuzumab Ozogamicin + Rituximab

Group Type EXPERIMENTAL

Inotuzumab Ozogamicin (CMC-544)

Intervention Type DRUG

1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Rituximab (Rituxan)

Intervention Type DRUG

375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Interventions

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Inotuzumab Ozogamicin (CMC-544)

1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Intervention Type DRUG

Rituximab (Rituxan)

375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
* Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
* Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
* Patients must not have received previous radioimmunotherapy.
* Patients tolerant to Rituximab.
* Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.

Exclusion Criteria

* Candidate for potentially curative therapies
* Subjects must not have received previous radioimmunotherapy.
* Subjects with autologous hematopoietic stem cell transplant within the last 6 months

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No