Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

NCT ID: NCT01329900

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-22
• Study Completion Date: 2019-07-21

Brief Summary

The goal of this clinical research study is to learn if it is possible to collect stem cells after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects, number of stem cells collected, and the number of procedures that are needed to collect enough stem cells.

Detailed Description

The Study Drugs:

Ofatumumab is a human monoclonal antibody for the CD20 protein designed to bind to the surface of some of the white blood cells (B-cells). It can destroy cancer cells that come from B-cells, and can be used to treat cancers of B-cells such as resistant CLL (chronic lymphocytic leukemia).

Etoposide is designed to slow or stop the growth of cancer cells.

Filgrastim promotes the growth of white blood cells, which help to fight infections.

Ifosfamide is designed to slow or stop the growth of cancer cells.

Mesna is a drug that protects bladder cells from damage by the chemotherapy drug ifosfamide. It is used to decrease the risk of bleeding in the bladder.

Treatment Administration:

You will be admitted to the hospital. You will have to stay in the hospital for 4-6 days for this part of the treatment.

On Day 1, you will receive ofatumumab through the CVL over 6-8 hours.

On Days 2, 3, and 4, you will receive ifosfamide and mesna continuously and etoposide every 12 hours. Mesna is given to help decrease the risk of developing side effects.

As an outpatient, you will receive a higher dose of ofatumumab (about 1 week after the first one) through the CVL over 10-12 hours.

Beginning on Day 6, you will get G-CSF (filgrastim) injections (given under the skin) and will continue to be given until enough stem cells have been collected.

Tests and Procedures:

Every day while you are in the hospital, you will have a physical exam and you will be asked about any side effects you may be having. After you are no longer in the hospital, you will have a physical exam and you will be asked about any side effects you may be having when the doctor thinks it is needed.

While you are waiting for enough stem cells to be collected, you will have blood drawn (about 1 tablespoon) for routine tests at least 3 times a week. If your doctor thinks it is needed, you may have blood drawn more often.

Stem Cell Collection:

Blood stem cells will be collected when your blood counts have returned to normal (about 10-16 days after chemotherapy). The process of stem cell collection takes about 4 hours each time. You will have stem cells collected each day until enough are collected (between 1-6 sessions). A machine is attached to the CVL and blood is withdrawn. The blood then flows through the machine, which removes stem cells from the blood. The blood is then returned back to you through the CVL. The stem cells are then frozen and stored. These stem cells will be given back to you after the next phase of treatment to help your blood counts recover after high dose chemotherapy. After enough stem cells have been collected, you will be admitted to the hospital for high dose chemotherapy. You will sign a separate consent before you receive high dose chemotherapy.

During the stem cell collection, blood (about 2 teaspoons) will be drawn through the CVL to check for cell markers that can affect the response of the cell counts and to check the status of the disease.

Length of Study:

Patients will be followed for up to 12 months after the transplant. You will be taken off study early if the stem cell collection does not work.

This is an investigational study. Etoposide and ifosfamide are FDA approved and are commercially available for lymphomas. Ofatumumab has been approved by the FDA for treatment of recurrent refractory chronic lymphocytic leukemias. G-CSF and Mesna are FDA approved and commercially available. The use of Ofatumumab for the collection of stem cells is investigational.

Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ofatumumab + Stem Cell Collection

Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Group Type: EXPERIMENTAL

Ofatumumab

Intervention Type: DRUG

1000 mg by vein on Day 1 and 2000 mg by vein on Day 8

Ifosfamide

Intervention Type: DRUG

3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.

Etoposide

Intervention Type: DRUG

150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.

Mesna

Intervention Type: DRUG

2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)

2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)

After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose.

G-CSF

Intervention Type: DRUG

6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.

Stem Cell Collection

Intervention Type: PROCEDURE

Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Interventions

Ofatumumab

1000 mg by vein on Day 1 and 2000 mg by vein on Day 8

Intervention Type: DRUG

Ifosfamide

3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.

Intervention Type: DRUG

Etoposide

150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.

Intervention Type: DRUG

Mesna

2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)

2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)

After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose.

Intervention Type: DRUG

G-CSF

6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.

Intervention Type: DRUG

Stem Cell Collection

Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Intervention Type: PROCEDURE

Other Intervention Names

Arzera; Ifex; VePesid; Mesnex; Filgrastim; Neupogen; Granulocyte colony-stimulating factor; GCSF; Apheresis

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for autologous SCT.

2. Patients must have PR to salvage chemotherapy.

3. Age 18-70 years.

4. Platelet count >/= 100,00 mm³ independent of transfusion support.

5. Absolute neutrophil count >/= 1500/mm³.

6. Zubrod performance status (PS) 2 or less.

7. Negative serum pregnancy test in women of childbearing potential. This is a female who has not been postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization.

8. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy.

9. Seronegativity for HIV, HTLV1, Hepatitis .

Exclusion Criteria

1. Subjects who have current active hepatic ( (HbsAg, HbcAb, and positive viral load by PCR) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) with ALT > 2x upper limit of normal or bilirubin > 1.5. (Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.)

2. Active CNS disease.

3. Severe concomitant medical or psychiatric illness.

4. Lactating or breast feeding females.

5. Serum creatinine >1.6 mg/dl.

6. History of pelvic radiation.

7. Fludarabine-based chemotherapy within 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Issa F. Khouri, MD,BS

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Official Website

Other Identifiers

NCI-2011-01068

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-0796

Identifier Type: -

Identifier Source: org_study_id