MDACC Study Summary BMTCTN07 01

Study Summary
No. BMTCTN07 01:.......Blood And Marrow Transplantation; Lymphoma......Chitra M. Hosing......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	BMTCTN07 01

Study Title:	Phase II Trial of Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed Follicular non -Hodgkin's Lymphoma beyond First Complete Response

Physician

New Patient Referral



Name:	Chitra M. Hosing	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Lymphoma	Supported By:	BMT CTN

Phase of Study:	Phase II	Return Visit:	Daily for 100 days after transplantation, then 6, 12, 18, and 24 months after transplantation

Treatment Agents:	Cytoxan Fludarabine Methotrexate Stem Cell Transplantation Tacrolimus	Home Care:	Patients may receive IV antibiotics, IV fluids at home.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Three weeks for transplant

Description/
Intervention:

The goal of this clinical research study is to learn the effects of a
lower-intensity type of stem cell transplant for follicular non-Hodgkin's
lymphoma. The transplant is lower intensity because rather than using high
doses of chemotherapy as is routine for a transplant, the standard doses of
chemotherapy are given. The chemotherapy drugs being tested in this study are
rituximab, cyclophosphamide, and fludarabine.

The safety of this study treatment will also be studied.

Study Objectives / Outcomes

Primary Objective

To measure progression free survival at two years after non-myeloablative hematopoietic stem cell transplantation (HSCT) with a transplant conditioning regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in patients who are less than or equal to 75 years of age.

Secondary Objectives
· 2-year overall survival
· Time to progression/ relapse
· Time to Complete Response and Partial Response
· Time to off study therapy
· Grade II-IV and III-IV acute graft versus host disease (GVHD)
· Chronic GVHD
· Incidence of primary and secondary graft-failure
· Quality of Life (QOL) measurements
· Correlation of serum rituximab levels with development of acute GVHD, chronic GVHD, relapse and immune recovery
· Treatment-related mortality
· Infections
· Toxicities
· Immune reconstitution

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	05/22/2009

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	65

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with confirmed CD20+ follicle center lymphoma that meet the following: a. Histologically confirmed recurrent REAL classification CD20+ follicle center lymphoma, follicular grades I and II, OR b. Histologically confirmed WHO classification CD20+ follicular lymphoma grades 1, 2, or 3a For either classification, the diffuse component of large cleaved cells (if present) cannot be > 50% of cellularity. Patients do not have to express t(14;18) to be eligible.

2) Age </= 75 years of age at time of first registration.

3) Any number of prior regimens (including autologous HCT). The most recent prior regimen must have occurred > 28 days before study enrollment.

4) Patients must demonstrate chemo-sensitive or radiosensitive disease to most recent prior regimen and meet one of the following: a. Patients in 2nd or subsequent CR OR b. Patients in 1st or subsequent PR c. Patients experiencing a relapse that demonstrates a response as defined below: Response is defined as largest nodal mass </= 3 cm and >/= 50% reduction in estimated lymph node volume measured as a product of bi-dimensional measurements. Patients with stable follicular lymphoma are eligible if all lymph node masses are </= 3 cm and are smaller or unchanged in size to the most recent salvage regimen.

5) Patients with HLA-matched donors that meet the following criteria: a. 6/6 HLA-matched related donor. HLA typing must be performed by DNA methods for HLA-A and B at intermediate (or higher) resolution, and DRB1 at high resolution. The donor must be willing to donate peripheral blood stem cells and meet institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to individual transplant center criteria. OR

6) contd from 5. b. 8/8 HLA-matched unrelated donor. HLA typing must be performed by DNA methods for HLA-A, B, Cand DRB1 at high resolution. The donor must be willing to donate peripheral blood stem cells and meet NMDP criteria for stem cell donation. The donor must be medically eligible to donate stem cells according to NMDP criteria.

7) Patients with adequate organ function as measured by: a. Cardiac: Left ventricular ejection fraction at rest > 45%. b. Pulmonary: DLCO, FEV1, FVC > 50% of predicted (corrected for hemoglobin). For patients where pulse oximetry is performed, baseline O2 saturation > 85% (when pulmonary function testing cannot be performed due to age restrictions). c. Hepatic: Bilirubin < 2x the upper limit of normal for age as per local laboratory; ALT and AST < 3x the upper limit of normal as per local laboratory.

8) contd from 7. d. Renal: Calculated or measured creatinine clearance >/= 40 mL/min; if creatinine >/= 1.5 mg/dL then 24 hour urine for measured creatinine clearance should be performed

9) Signed informed consent form.

10) Donor Inclusion Criteria The donor must be medically eligible and consent to donate stem cells according to individual transplant center criteria for related donors or NMDP criteria for unrelated donors.

Exclusion Criteria:

1) Patients in 1st CR.

2) Karnofsky performance score < 70%.

3) Patients with follicular lymphoma that demonstrates evidence of histologic transformation. In the presence of B symptoms, rapid growth of a single dominant site, or prolonged (> 2yrs) interval since last tissue diagnosis, investigators are encouraged to consider re-biopsy of nodes prior to enrollment.

4) Patients with uncontrolled hypertension

5) Patients with uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)

6) Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years will not be allowed unless approved by the Medical Monitor or Protocol Chair. Cancer treated with curative intent > 5 years will be allowed.

7) Pregnant (beta HCG+) or breastfeeding

8) Seropositive for human immunodeficiency virus (HIV).

9) Fertile men or women unwilling to use contraceptive techniques from the time of initiation of conditioning until six-months post-transplant.

10) Prior allogeneic HSCT.

11) Known anaphylactic reaction to rituximab.

12) Seropositive for any of the following: HIV ab, hepatitis B sAg or PCR+ or hepatitis C ab or PCR+.

13) Donor Exclusion Criteria for Matched Related Donors: 1. A sibling donor cannot be an identical twin of the patient. 2. Infection with HIV, viral hepatitis (B or C). 3. Donors receiving experimental therapy or investigational agents. 4. Donors with cancer other than treated basal cell or carcinoma in situ of cervix. Cancer treated with curative intent < 5 years will not be allowed unless approved by the Medical Monitor or Protocol Chair. Cancer treated with curative intent > 5 years will be allowed.

Links

Registration Number: NCT00867074
Study Information on Clinical Trials Registry (clinicaltrials.gov)