Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Anti-Infective Agents

All Drugs and Chemicals

Plerixafor

Lenograstim

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

AMD3100

G-CSF

Apheresis

Amanda F. Cashen, M.D.

This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma.

The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.

Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse after a chemotherapy-induced complete remission. For these patients, as for other patients undergoing autologous transplantation, the number of CD34+ cells collected is a reliable predictor of neutrophil and platelet (PLT) engraftment after transplantation.

AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis, which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34+ cell count, so that the drug can be administered the same day as apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the number of CD34+ cells collected via apheresis.

This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas.

Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma

A Phase I/II Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma

* MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.
* DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.

Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.

Washington University School of Medicine

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Phase II

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Phase 1 (Dose Levels 1-4)

Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)

Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study

Phase 1 and Phase 2 Participants

Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration

Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype

Hemoglobin

Leukocytes (WBC)

Lymphopenia

Neutrophils (ANC)

Platelets

Alkaline phosphtase

SGPT (ALT)

Hypoxia

Hypotension

Mucositis

Infection with neutropenia

Febrile neutropenia

Bleeding at catheter site

Hemorrhage - spleen

Atrial fibrillation

Diarrhea

Ileus

Nausea

Vomiting

Hyperbilirubinemia

Fungal infection

Opportunistic infection

Clostridium difficile

Colitis

E. coli infection

Leptotrichia

Lung infection (pneumonia)

Staph infection

Typhlitis

Glucose - high

Magnesium - high

Potassium - low

Sodium - low

Cough

240 µg/kg SC AMD3100 Day -5

10 µg/kg SC G-CSF Day -4 thru Day -1

MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1

Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

AMD3100

G-CSF

Apheresis

Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 1

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 2

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* 320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 3

240 µg/kg SC AMD3100 Day -5 10 µg/kg SC G-CSF Day -4 thru Day -1 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1 Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I - Cohort 4

* 240 µg/kg SC AMD3100 Day -5
* 10 µg/kg SC G-CSF Day -4 thru Day -1
* MTD as determined in Phase I IV AMD3100 and 10 µg/kg SC G-CSF Day 1
* Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)

Phase I

Spots Global Cancer Trial Database for receptors, cxcr4