Hodgkin's Lymphoma
Conditions
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).
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.
Interventions
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
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Stage Disease 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 | 5 |
| Advanced Stage Disease 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 | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Early Stage Disease | Advanced Stage Disease | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
36-Month Progression-free Survival Rate
Progression-free survival is defined as the length of time from study intervention to disease progression or death
Time frame: 36 months
Population: Data was not collected due to early termination of the study.