Stem Cell Transplant for Non-Hodgkin's Lymphoma

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, HIV, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for high-risk non-Hodgkin's lymphoma, a cancer affecting the lymphatic system. It employs a two-step approach: first, a transplant using a patient's own blood stem cells (known as Autologous Hematopoietic Stem Cell Transplantation), followed by a second transplant from a donor to assess long-term disease control. Suitable candidates for this trial have previously undergone a stem cell transplant but continue to face aggressive lymphoma or have experienced a relapse. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown promising safety results for non-myeloablative allogeneic stem cell transplants. Research indicates that about 83% of patients experienced progression-free survival, meaning their disease did not worsen for a certain period. However, some patients faced complications. Specifically, one study reported a 28% rate of deaths due to treatment side effects, which is higher than with other types of transplants.

Despite these risks, non-myeloablative transplants are often considered because they are less intense than traditional transplants, potentially making them easier for some patients to handle. It is crucial to weigh the potential benefits against the risks when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for Non-Hodgkin's Lymphoma because it uses autologous hematopoietic stem cell transplantation, which is different from the usual chemotherapy and radiation. Unlike standard chemotherapy, which targets and kills rapidly dividing cells, this treatment involves transplanting the patient's own stem cells to help regenerate healthy blood cells after high-dose chemotherapy. The unique combination of treatments, including total lymphoid irradiation and medications like anti-thymocyte globulin, aims to prepare the body efficiently for stem cell infusion and reduce the risk of complications. This approach is promising as it could offer a more targeted and potentially less toxic alternative to conventional therapies.

What evidence suggests that this trial's treatments could be effective for non-Hodgkin's lymphoma?

Research has shown that non-myeloablative allogeneic transplantation, one of the treatment arms in this trial, can be promising for treating non-Hodgkin's lymphoma. In one study, 67% of patients responded well to this treatment three months after receiving it. For patients with certain types of lymphoma, such as DLBCL, who have limited options if their cancer returns, this method offers hope. Long-term data indicate that while some patients still face challenges, such as disease recurrence, many achieve stable outcomes. This approach uses less intense treatments, which can be easier on the body while still effectively aiming to control the lymphoma. ^{1 2 3 6 7}

Who Is on the Research Team?

Keith Stockerl-Goldstein

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with high-risk non-Hodgkin's lymphoma who've had a stem cell transplant using their own cells. They must be in partial remission, have a matched donor ready, and agree to birth control. Excluded are those with prior radioimmunotherapy, progressive disease post-transplant, HIV-positive individuals or other recent cancers.

Inclusion Criteria

Serum bilirubin < or = 2 x the institutional ULN

Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

My blood counts are stable after a stem cell transplant, and I have a suitable donor.

Exclusion Criteria

Pregnant or breast-feeding women

I have had cancer before, but I've been cancer-free for 5 years, except for certain skin cancers or in situ cervical cancer.

I have had a stem cell transplant more than 120 days ago or never had one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive second-line chemotherapy for cytoreduction and to establish sensitivity to chemotherapy

6-9 weeks

Multiple visits for chemotherapy administration

Autologous Transplant

Participants undergo autologous hematopoietic stem cell transplant with high-dose chemotherapy

Approximately 60-120 days

Inpatient stay for transplant procedure

Allogeneic Transplant

Participants receive a non-myeloablative allogeneic transplant with total lymphoid irradiation and anti-thymocyte globulin

14 days

Inpatient stay for transplant procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Hematopoietic Stem Cell Transplantation
• Non-myeloablative Allogeneic Transplantation

Trial Overview The study tests if adding a second stem cell transplant from another person after an initial self-donated transplant can better control lymphoma. It involves drugs like Anti-thymocyte globulin and Tacrolimus to help the body accept the new cells.

How Is the Trial Designed?

Group I: Allogeneic Transplant Experimental Treatment 6 Interventions

* TLI - 80 cGy on days -14, -11, -10, -9, -8, -7, -4, -3, -2, -1 * Anti-thymocyte globulin (ATG) 1.5 mg/kg on days -11, -10, -8, -7 * Solumedrol - 1 mg/kg on days -11, -10, -9, -8, -7 * Tacrolimus - beginning on day -3 with starting dose of 0.3 mg/kg PO BID. Will be continued per institutional guidelines. * Stem cell infusion - day 0 * Mycophenolate mofetil (MMF) - beginning on day 0 with dose of 15 mg/kg PO (5-10 hours after transplant)

Autologous Hematopoietic Stem Cell Transplantation is already approved in United States, European Union for the following indications:

Approved in United States as Autologous Hematopoietic Stem Cell Transplantation for:

• Various hematologic malignancies including non-Hodgkin lymphoma, multiple myeloma, and leukemia

Approved in European Union as Autologous Stem Cell Transplant for:

• Non-Hodgkin lymphoma
• Multiple myeloma
• Leukemia
• Other hematologic malignancies

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454283/

Non-myeloablative Allogeneic Stem Cell Transplantation ... In this review, we discuss the current status of non-myeloablative allogeneic transplantation in the major lymphoma subgroups.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725012205

Long-Term Outcomes After Allogeneic Hematopoietic Stem ... Overall, 56 patients (19.6%) died from lymphoma progression, with 1-yr and 3-yr CIF of disease-related death of 15.9% (95% CI: 11.9 to 20.5) and 18.5 (14.2 to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2654416/

Non-myeloablative allogeneic hematopoietic cell ... Patients with DLBCL who relapse after, or are ineligible for, autologous HCT have a poor prognosis with conventional therapy. This study provides evidence that ...

4. astctjournal.org astctjournal.org/article/S1083-8791(05)00673-7/fulltext

Nonmyeloablative Stem Cell Transplantation Is an Effective ... Acute GVHD developed in 18 patients (45%). Chronic GVHD developed in 17 (45%) of the 31 evaluable patients. The response rate 3 months after the allo-RIC was 67 ...

5. ashpublications.org ashpublications.org/blood/article/111/1/446/107942/Outcomes-after-allogeneic-hematopoietic-cell

Outcomes after allogeneic hematopoietic cell transplantation ... After HCT, patients without comorbidities both in the nonmyeloablative and myeloablative cohorts had comparable NRM (P = .74), overall survival (P = .75), and ...

6. aetna.com aetna.com/cpb/medical/data/400_499/0494.html

Hematopoietic Cell Transplantation for Non-Hodgkin's ... As expected the toxic death rate was higher among allogeneic transplants (28 % versus 14 %). Among the subgroups of lymphoma, allogeneic transplant only showed ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15197204/

Nonmyeloablative allogeneic hematopoietic transplantation Conclusion: These data suggest that nonmyeloablative allogeneic stem-cell transplantation is an effective option in lymphoma patients with chemosensitive or ...