Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Bendamustine Hydrochloride; Cytarabine; Etoposide; Etoposide phosphate; Melphalan

Criteria

Inclusion Criteria:

1. Patients being able to meet all requirements of the clinical trial, according to the investigator's criteria,

2. Patient giving voluntarily written informed consent before performing any essay test that is not part of routine care of patients.

3. Age >o=18 years and >0=70 years

4. Candidate for chemotherapy (QT) at high doses and ASCT

1. Histologically confirmed aNHL:

2. Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in sensitive relapse, so, in second complete or partial response, after a minimum of 2 cycles of the rescue regimen.

3. Patients with DLBCL or grade 3 b Follicular lymphoma or PTCL (including anaplastic ALK +) in first complete or partial response, if more than one treatment line have been required to reach this first complete or partial response.

4. Transformed B cell lymphoma in first CR

5. Patients with PTCL (other than anaplastic ALK +) in first CR

5. Performance status (ECOG) <0=2.

6. Adequate renal, hepatic, and bone marrow function (assessed < 14 days before initiation of the study treatment):

1. Neutrophil count2. Platelet count

3. Haemoglobin

4. Creatinine serum >o=1,5 x ULN mg/dl

5. Serum bilirubin

6. AST, ALT

7. Adequate pulmonary function: forced expiratory volume at 1 second > 65% of predicted or a diffusing capacity of the lung for CO >o=50%.

8. Cardiac ejection fraction or greater than 50% by echocardiogram or FEVI.

9. A woman capable of gestation (see definition below) should:

• Have two medically supervised negative pregnancy test (minimum sensitivity of 25 mIU / ml) before starting study therapy (the first pregnancy test should be completed in 10 to 14 days prior to initiating bendamustine and the latter pregnancy test 24 hours before the start of this drug).

• Commit to a continued abstinence of heterosexual relationship or agree to use reliable contraception without interruption, 28 days before starting the study therapy, during the study therapy and for 28 days after stopping therapy study.

A woman capable of gestation is defined as sexually mature woman who:

1. has not undergone hysterectomy or bilateral oophorectomy and

2. is not naturally postmenopausal (amenorrhea as a result of cancer treatment does not rule the reproductive potential) for at least 24 consecutive months (i.e., menses at any time during the previous 24 consecutive months).

Exclusion Criteria:

1. Impossibility of collecting, via apheresis, a number of CD34+ cells >o=2 x 106/kg

2. To receive any of the following treatments in the 28 days before the start the study treatment:

i.chemotherapeutic or antitumor agents ii.radiation therapy, except in limited fields, to a maximum dose of iii.glucocorticoids, except doses equivalent to with a duration

3. Known involvement of the central nervous system (CNS) by lymphoma

4. Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure NYHA class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders.

5. Other serious or uncontrolled medical condition, such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease.

6. Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation.

7. Presence of any limitations that compromise the patient's ability to comply with the study treatment.

8. Positive serology for HIV, HCV or HBV surface antigen (HBsAg). If the HBsAg is negative but anti-core antibodies (HBcAb) are positive and antibody against surface antigen (HBsAb) are negative, there will be a HBV DNA test; If positive results the patient may not be included in the trial. If both types of antibodies HBcAb and HBsAb are positive (indicative of past infection), the patient may be included in the study.

9. Previous history of malignancies other than lymphoma (except basal cell or squamous cell skin carcinoma and carcinoma in situ of the cervix or breast) unless the patient is free of disease beyond 5 years.

10. Major surgery procedure within 30 days prior to entering this study.

11. Pregnant or nursing females.