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Leukemia

TREC for Relapsed or Refractory Lymphoid Malignancies (PSOC 2502)
A Phase I Trial of Bendamustine/Treanda, Rituxmab, Etoposide, and Carboplatin (TREC) for Patients With Relapsed or Refractory Lymphoid Malignancies
Status Conditions Phase Study ID
Closed Lymphoma Phase I PSOC 2502
NCT01165112
Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with relapsed or refractory lymphoid malignancies.


Investigator
Ajay K. Gopal, MD Lihua Elizabeth Budde, MD, PhD
Location    
Fred Hutchinson Cancer Research Center 206-667-4174  
Overlake Hospital Medical Center, Bellevue WA 425-688-5407  
Providence Alaska Medical Center, Anchorage AK 907-212-3109  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T- cell, or Hodgkin's lymphoma), or untreated lymphomas that are not curable with anthracycline based therapy (e.g. MCL, FL, MZL, LPL); patients with other lymphomas that have not received any prior therapy and are not candidates for anthracycline based therapies, are eligible with PI review and approval

- WHO classification of patient's malignancies must be provided

- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by CT, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; (Note: CT scans remain the standard for evaluation of nodal disease)

- Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of lymphadenopathy in the neck must have a CT of neck

- Patients should not have evidence of active central nervous system lymphoma

- Patients must have an ECOG performance status of 0, 1, or 2

- Adequate Bone Marrow Function: ANC >= 1,500/mm^3, platelets >= 100,000/mm^3 (without transfusion or growth factor support)

- Adequate Renal Function: serum creatinine < 1.5 mg/dl or creatinine clearance greater than 50/ ml per minute

- Adequate Hepatic function: total bilirubin < 1.5 times upper limit of normal, AST and ALT < 2.5 times upper limit of normal

- Patients must have a serum LDH performed within 14 days prior to registration

- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines

- Patients must be anticipated to complete at least 2 cycles of chemotherapy

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Patients known positive for HIV, or infectious hepatitis type B or C

- Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol Chair or Co-Chair

- Patients who are refractory (i.e. not responded or progressed within 6 months) to a carboplatin, cisplatin, bendamustine, or etoposide-based regimen

- Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia); if the patient's cardiac history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction < 50% are not eligible

- Autologous or allogeneic transplantation within 12 months or radioimmunotherapy within 6 months of registration; prior failed (< 5x10^6 CD34/kg) peripheral blood stem cell (PBSC) collection

- Patients who had pelvic radiation within 12 months or received more than 2 prior therapies with myelotoxic regimens; single agent monoclonal antibody treatment is not considered as one therapy; radiation treatment following chemotherapy is not considered as one separated therapy

- Previous chemotherapy/immunotherapy within 3 weeks before study entry

- Concurrent use of other anti-cancer agents or experimental treatments

- Known hypersensitivity to bendamustine, mannitol, etopiside, carboplatin, or rituximab

Other exclusion criteria may apply.

Last Updated
August 21, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.