Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography (PET) Scan in Hodgkin's Lymphoma
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Early Stage Disease Group A |
Drug: ABVD chemotherapy
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
|
| Other: Advance Stage Disease Group B |
Drug: ABVD chemotherapy
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
|
Outcome Measures
Primary Outcome Measures
- 36-Month Progression-free Survival Rate [36 months]
Progression-free survival is defined as the length of time from study intervention to disease progression or death
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medical College | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Rebecca Elstrom, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0810010015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Early Stage Disease | Advanced Stage Disease |
|---|---|---|
| Arm/Group Description | Group A ABVD chemotherapy: 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 | Group B ABVD chemotherapy: 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 |
| Period Title: Overall Study | ||
| STARTED | 5 | 1 |
| COMPLETED | 5 | 1 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Early Stage Disease | Advanced Stage Disease | Total |
|---|---|---|---|
| Arm/Group Description | Group A ABVD chemotherapy: 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 | Group B ABVD chemotherapy: 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 | Total of all reporting groups |
| Overall Participants | 5 | 1 | 6 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
100%
|
1
100%
|
6
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
3
60%
|
1
100%
|
4
66.7%
|
| Male |
2
40%
|
0
0%
|
2
33.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
5
100%
|
1
100%
|
6
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
20%
|
0
0%
|
1
16.7%
|
| White |
4
80%
|
1
100%
|
5
83.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
5
100%
|
1
100%
|
6
100%
|
Outcome Measures
| Title | 36-Month Progression-free Survival Rate |
|---|---|
| Description | Progression-free survival is defined as the length of time from study intervention to disease progression or death |
| Time Frame | 36 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected due to early termination of the study. |
| Arm/Group Title | Group A | Group B |
|---|---|---|
| Arm/Group Description | early stage disease ABVD chemotherapy: 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 | advanced stage disease ABVD chemotherapy: 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 |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | Zero subjects at risk for adverse events as this was not evaluated due to early study termination. | |||
| Arm/Group Title | Early Stage Disease | Advanced Stage Disease | ||
| Arm/Group Description | Group A ABVD chemotherapy: 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 | Group B ABVD chemotherapy: 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 | ||
All Cause Mortality |
||||
| Early Stage Disease | Advanced Stage Disease | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Early Stage Disease | Advanced Stage Disease | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Early Stage Disease | Advanced Stage Disease | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
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.
Results Point of Contact
| Name/Title | Dr. Peter Martin |
|---|---|
| Organization | Weill Cornell Medicine |
| Phone | |
| pem9019@med.cornell.edu |
- 0810010015