Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Alemtuzumab

Antineoplastic Agents, Immunological

CAMPATH (alemtuzumab)

Medical Monitor

The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.

This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.

Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL

Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma

Genzyme, a Sanofi Company

Hematologic Neoplasms

Hematologic Diseases

This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.

Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL	NCT00077961	Non-Hodgkin's L...	CAMPATH (alemtu...	18 Years -	Sanofi
Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies	NCT00113048	Hematologic Mal...	CAMPATH (alemtu...	18 Years -	Sanofi
Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL	NCT00077961	Non-Hodgkin's L...	CAMPATH (alemtu...	18 Years -	Sanofi

Spots Global Cancer Trial Database for campath (alemtuzumab)