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CompletedNCT00952237Updated Apr 25, 2018

Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

A Phase 1 interventional study of GM-CSF and IL-2 in Non-Hodgkin's Lymphoma, Hodgkin's Disease and Multiple Myeloma, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

We postulate that the combination of IL-2 and GM-CSF immunotherapy will efficiently mobilize autologous peripheral blood stem cells and activated immune effector cells in patients with a hematologic malignancy. These activated effector cells will improve the immune function of the graft. These hypotheses will be tested using this proposed clinical trial to mobilize autologous peripheral blood stem cells pre-transplantation.

02

Conditions studied

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Other Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis)
  • Leukemia

Keywords

  • Autologous Peripheral Blood Stem Cell Transplant
  • IL-2
  • GM-CSF
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients must have pathologic diagnosis of one of the following malignancies: Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma or other plasma cell dyscrasia (Waldenstrom, Amyloidosis), Leukemia (AML, ALL, CLL)
  • Prior Treatment: > 2 weeks prior to initiation of therapy.
  • Performance Status: Karnofsky > 70%
  • Age >18
  • Life Expectancy > 4 months
  • Bone Marrow: bone marrow biopsy and aspirate
  • Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 mg/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
  • Pulmonary function tests: DLCO > 55% predicted.
  • Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
  • Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) \< 3 x normal (unless believed to be elevated due to disease).
  • No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
  • Informed Consent: Informed consent must be signed prior to the treatment. Patients must be aware of the neoplastic nature of their disease and willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. The patient is not deemed eligible if there is any other serious medical or psychiatric illness that would prevent informed consent. (Human protection committee approval of this protocol and a consent form is required.)

Exclusion criteria

Exclusion Criteria:

  • Medical, social, or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy.
  • Evidence on physical exam, LP, CT, or MRI scans of CNS involvement with malignancy.
  • Uncontrolled or severe cardiovascular disease, including recent (\< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening arrhythmia, or hypertension or clinically significant obstructive/restrictive pulmonary disease.
  • Serology positive for HIV
  • History of seizures.
  • Concurrent or expected need for therapy with systemic corticosteroids (since systemic steroids may suppress the effects of IL-2).
  • Current and clinically significant pleural effusion, pericardial effusion, or ascites.
  • Positive pregnancy test or presence of lactation.
  • Uncontrolled active infection.
  • Documented hypersensitivity to any of the drugs used in the protocol.
  • No concomitant, ongoing malignancy that is life-threatening, based on PI's evaluation
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    IL-2 and GM-CSF for Mobilization

    Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

    Drug: GM-CSF · Drug: IL-2

Interventions

  • DrugGM-CSF

    GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis. G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis.

  • DrugIL-2

    IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis. Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0). Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above

06

What researchers measure

Primary outcomes

  1. Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.

    Time frame: 5 Years

Secondary outcomes

  1. Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.

    Time frame: 5 Years

07

Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00952237
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Kenneth Meehan (Director, Bone Marrow Transplant Program, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Aug 6, 2009
Start date
Jan 2003
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Apr 25, 2018

Study contacts

Kenneth R Meehan, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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