Know Cancer

or
forgot password

Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma

Thank you

Trial Information

Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy


Inclusion Criteria:



- Signature of the written informed consent by the subject or his/her legal
representative before initiation of any trial specific procedure.

- Patients older than 18.

- Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO
classification.

- High-risk patients according to FLIPI before initiation of induction chemotherapy.

- Stage II-IV prior to initiation of induction treatment, or any stage in patients with
grade 3 follicular lymphoma.

- Complete or partial response to the induction scheme.

- ECOG scale performance status 0 - 2.

- Life expectancy greater than 3 months.

- In women of childbearing age, use of a reliable contraceptive method.

- A suitable bone marrow reserve:

- Lower than 25% Bone marrow infiltration by lymphoma.

- Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3

- Suitable hepatic, renal and cardiac function:

- creatinine <2,5 x UNL (upper normality limit).

- bilirubin or ALT/AST < 2,5 x UNL

Exclusion Criteria:

- Patients with no objective clinical response to induction chemotherapy.

- > 25% bone marrow infiltration following induction chemotherapy.

- Platelets < 100,000 before radioimmunotherapy.

- Severe and/or uncontrolled concomitant disease:

- Hepatic, renal, cardiovascular, neurological or metabolic disease.

- Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of
myocardial infarction or angor, or major ventricular arrhythmia.

- Positive regarding HBV, HCV, HIV.

- Active acute or chronic infection.

- Social, psychic or geographic disability to satisfy any of the treatment schemes.

- Pregnant and/or breastfeeding women, or adult patients of childbearing age who are
not using a safe birth control device throughout the study treatment and at least 12
months thereafter.

- Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to
the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a
history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other
anthracyclines, cytarabine).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease

Outcome Time Frame:

12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter

Safety Issue:

No

Principal Investigator

Mariano Provencio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ClĂ­nica Puerta de Hierro

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GOTEL-FL1LC-0701

NCT ID:

NCT00722930

Start Date:

April 2008

Completion Date:

April 2013

Related Keywords:

  • Follicular Lymphoma
  • Follicular Lymphoma
  • High-risk FLIPI
  • R-CHOP
  • GOTEL
  • Partial
  • Complete
  • Response
  • Induction
  • Chemotherapy
  • Lymphoma
  • Lymphoma, Follicular

Name

Location