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Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma


N/A
12 Years
65 Years
Open (Enrolling)
Both
Hodgkin's Lymphoma

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Trial Information

Phase II Study of Interim PET-CT Scan-guided Response Adapted Therapy in Hodgkin's Lymphoma


Inclusion Criteria:



- Age 12-65 years old

- Newly diagnosed histology proven patients of advanced HL (stage IIb, III and IV)

- Patients' performance status ECOG 0-2

- Normal hematopoetic parameters except if due to marrow involvement by disease (WBC >
4000/cmm, Platelet count > 100,000/cmm)

- No uncontrolled hepatitis B/C infection; and normal LFT values with s -Bilirubin,
SGOT and SGPT not more than 2.5 times upper limit of normal (unless initially due to
liver involvement by disease)

- Serum Creatinine ≤ 2mg/dL unless elevated due to involvement by disease

- Cardiovascular/ Metabolic: No severe cardiac disease that would limit normal life
expectancy or preclude study. LVEF at least 50%; Controlled blood glucose if
diabetic; controlled Blood pressure if hypertensive

- Pulmonary: No severe pulmonary disease that would limit normal life expectancy or
preclude study

- Others: HIV negative status; No prior haematological cancers or chemotherapy or
radiation therapy in the past

Exclusion Criteria:

- Pregnancy

- Nursing mothers

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

toxicity of escalated BEACOPP in advanced hodgkin's lymphoma with interim PET scan positivity

Outcome Description:

this is a pilot study looking at the feasibility of delivering escalated Beacopp in the Indian population where there is no data on the delivery of the same. So the investigators are soliciting a group of patients who have a high risk of failure as defined by interim PET positivity after 2 cycles of ABVD chemotherapy. The investigators look at toxicity issues of this high intensity protocol

Outcome Time Frame:

Once every 6 months

Safety Issue:

Yes

Principal Investigator

Prasanth Ganesan, MD, DM

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute (WIA) , Adyar, Chennai

Authority:

India: Institutional Review Board

Study ID:

CIA-HL-1

NCT ID:

NCT01304849

Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • PET CT scan
  • Escalated BEACOPP
  • ABVD
  • Response adapted therapy
  • Hodgkin Disease
  • Lymphoma

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