Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma

NCT00901303 | Terminated Results

• 1 other identifier: 0810010015
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine the progression-free survival \[PFS\] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).

Conditions

Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 36-Month Progression-free Survival Rate

  Progression-free survival is defined as the length of time from study intervention to disease progression or death

  36 months

Study Arms (2)

Early Stage Disease

OTHER

Group A

Drug: ABVD chemotherapy

Advance Stage Disease

OTHER

Group B

Drug: ABVD chemotherapy

Interventions

ABVD chemotherapy DRUG

Adriamycin 25 mg/m2 bleomycin 10 units/m2 vinblastine 6 mg/m2 dacarbazine 375 mg/m on Days 1 and 15 of each 28 day cycle

Advance Stage Disease; Early Stage Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
• No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
• Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and \> 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
• Age ≥ 18
• Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
• LVEF by ECHO or MUGA within institutional normal limits
• Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy

You may not qualify if:

• Patient has no known HIV infection
• Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
• No other history of lymphoproliferative disorder or granulomatous disease

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Peter Martin
• Organization: Weill Cornell Medicine

pem9019@med.cornell.edu

Study Officials

• Rebecca Elstrom, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 13, 2009
• Study Start: October 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: May 23, 2011
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Locations

US (1)