Rituximab and ABVD for Hodgkin's Patients

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00504504
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 85
• Location: 1
• Arm: 1
• Duration (Months): 132
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Primary Objective:

• To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Rituximab; Drug: Adriamycin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine (DTIC)	Phase 2

Detailed Description

Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
• Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Rituximab + ABVD Chemotherapy Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.

Drug: Rituximab; 375 mg/m^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.; Other Names: Rituxan ; Drug: Adriamycin; 25 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; Other Names: Doxorubicin Rubex ; Drug: Bleomycin; 10 U/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; Other Names: Bleomycin sulfate Blenoxane BLM ; Drug: Vinblastine; 6 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; Other Names: Vinblastine Sulfate Velban ; Drug: Dacarbazine (DTIC); 375 mg/m^2 injected by vein over 3 hours every other week for a total of 12 treatments.; Other Names: DTIC-Dome

Outcome Measures

Primary Outcome Measures

1. 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD [Baseline to 5 Years or until disease progression]

   Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.

2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).

3. Must have bidimensionally measurable disease.

4. Must sign a consent form.

5. Must be older than 16 years of age.

6. Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL

7. Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.

8. Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl

Exclusion Criteria:

1. HIV positive.

2. Pregnant women and women of child bearing age who are not practicing adequate contraception.

3. Prior chemotherapy.

4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT MD . Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• Genentech, Inc.

Investigators

• Principal Investigator: Anas Younes, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UT MD Anderson Cancer Center website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00504504
• Other Study ID Numbers: ID00-218
• First Posted: Jul 20, 2007
• Last Update Posted: Jul 9, 2013
• Last Verified: May 1, 2013

• Keywords provided by M.D. Anderson Cancer Center: Hodgkin's Disease; Lymphoma; Rituximab; Rituxan; Adriamycin; Doxorubicin; Rubex; Bleomycin; Bleomycin sulfate; Blenoxane; BLM; Dacarbazine; DTIC; DTIC-Dome; Vincristine; Vinblastine; Vinblastine Sulfate; ABVD; ABVD Chemotherapy Treatment
• Additional relevant MeSH terms: Hodgkin Disease; Rituximab; Doxorubicin; Liposomal doxorubicin; Dacarbazine; Bleomycin; Vinblastine

Study Results

Participant Flow

Recruitment Details	Recruitment Period: March 09, 2001 to August 29, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Detail	Of the 85 participants enrolled, three participants were excluded prior to assignment to groups as ineligible.

Arm/Group Title	Rituximab + ABVD Chemotherapy
Arm/Group Description	Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Period Title: Overall Study
STARTED	82
COMPLETED	82
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Rituximab + ABVD Chemotherapy
Arm/Group Description	Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Overall Participants	82
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	32
Sex: Female, Male (Count of Participants)
Female	41 50%
Male	41 50%
Region of Enrollment (participants) [Number]
United States	82 100%

Outcome Measures

1. Primary Outcome

Title	5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
Description	Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
Time Frame	Baseline to 5 Years or until disease progression

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rituximab + ABVD Chemotherapy
Arm/Group Description	Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
Measure Participants	82
Number [percentage of participants]	83 101.2%

Adverse Events

Time Frame	6 years and 5 months
Arm/Group Title	Rituximab + ABVD Chemotherapy
Arm/Group Description	Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
All Cause Mortality
	Rituximab + ABVD Chemotherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Rituximab + ABVD Chemotherapy
	Affected / at Risk (%)	# Events
Total	40/82 (48.8%)
Blood and lymphatic system disorders
Granuloctopenia	18/82 (22%)
Gastrointestinal disorders
Nausea	6/82 (7.3%)
Vomiting	1/82 (1.2%)
Constipation	1/82 (1.2%)
General disorders
Fatigue	7/82 (8.5%)
Pain	5/82 (6.1%)
Nervous system disorders
Neuropathy	1/82 (1.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/82 (1.2%)
Other (Not Including Serious) Adverse Events
	Rituximab + ABVD Chemotherapy
	Affected / at Risk (%)	# Events
Total	82/82 (100%)
Blood and lymphatic system disorders
Granuloctopenia	9/82 (11%)
Gastrointestinal disorders
Nausea	45/82 (54.9%)
Vomiting	28/82 (34.1%)
Diarrhea	16/82 (19.5%)
Constipation	19/82 (23.2%)
General disorders
Fatigue	32/82 (39%)
Pain	28/82 (34.1%)
Alopecia	35/82 (42.7%)
Nervous system disorders
Neuropathy	25/82 (30.5%)
Respiratory, thoracic and mediastinal disorders
Cough	16/82 (19.5%)
Dyspnea	15/82 (18.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.